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NCT01803282 · REGISTRY CONDITION SEARCH

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2020-06-02

The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

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outcome · POSTED

Percentage of Participants Experiencing Laboratory Abnormalities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Key Inclusion Criteria: * Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available * Part B: Pancreatic Adenocarcinoma * Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma * Part B: NSCLC * Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC * Absence of known epidermal growth factor receptor (EGFR) mutation * Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion) * Part B: Esophagogastric Adenocarcinoma: * Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma * Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion) * Part B: First-Line Colorectal Cancer * Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum * Radiographically measureable disease * No prior cytotoxic chemotherapy to treat their metastatic disease * Part B: Second-Line Colorectal Cancer * Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum * Radiographically measureable disease * Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion * Part B: Breast Cancer * Histologically or cytologically confirmed metastatic breast cancer * Radiographically measureable disease * Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed * Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician * HER-2 negative tumor (primary tumor or metastatic lesion) * Adequate organ function Key Exclusion Criteria: * Pregnant or lactating * Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids * Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months * Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted Note: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    label
    Part A: ADX 200 mg
    type
    EXPERIMENTAL
  2. description
    Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    label
    Part A: ADX 600 mg
    type
    EXPERIMENTAL
  3. description
    Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug
    intervention Names
    1. Drug: Andecaliximab
    label
    Part A: ADX 1800 mg
    type
    EXPERIMENTAL
  4. description
    Participants with PAC will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Gemcitabine
    3. Drug: Nab-paclitaxel
    label
    Part B: PAC, ADX 800 mg
    type
    EXPERIMENTAL
  5. description
    Participants with lung adenocarcinoma (LAC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Carboplatin
    3. Drug: Pemetrexed
    label
    Part B: LAC, ADX 1200 mg
    type
    EXPERIMENTAL
  6. description
    Participants with lung squamous cell carcinoma (LSC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Carboplatin
    3. Drug: Paclitaxel
    label
    Part B: LSC, ADX 1200 mg
    type
    EXPERIMENTAL
  7. description
    Participants with esophagogastric adenocarcinoma (EGC) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} \[mFOLFOX6\], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Leucovorin
    3. Drug: Oxaliplatin
    4. Drug: 5-FU
    label
    Part B: EGC, ADX 800 mg
    type
    EXPERIMENTAL
  8. description
    Participants with colorectal cancer (CRC) will receive first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Leucovorin
    3. Drug: Oxaliplatin
    4. Drug: 5-FU
    5. Drug: Bevacizumab
    label
    Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    type
    EXPERIMENTAL
  9. description
    Participants with CRC will receive FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Leucovorin
    3. Drug: Oxaliplatin
    4. Drug: 5-FU
    5. Drug: Bevacizumab
    label
    Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    type
    EXPERIMENTAL
  10. description
    Participants with CRC will receive second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU \[FOLFIRI\] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Leucovorin
    3. Drug: 5-FU
    4. Drug: Bevacizumab
    5. Drug: Irinotecan
    label
    Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    type
    EXPERIMENTAL
  11. description
    Participants with CRC will receive SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Leucovorin
    3. Drug: 5-FU
    4. Drug: Bevacizumab
    5. Drug: Irinotecan
    label
    Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    type
    EXPERIMENTAL
  12. description
    Participants with breast cancer (BRCA) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    intervention Names
    1. Drug: Andecaliximab
    2. Drug: Paclitaxel
    label
    Part B: BRCA, ADX 800 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A: ADX 1800 mg
    2. Part A: ADX 200 mg
    3. Part A: ADX 600 mg
    4. Part B: BRCA, ADX 800 mg
    5. Part B: EGC, ADX 800 mg
    6. Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    7. Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    8. Part B: LAC, ADX 1200 mg
    9. Part B: LSC, ADX 1200 mg
    10. Part B: PAC, ADX 800 mg
    11. Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    12. Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenous infusion
    name
    Andecaliximab
    other Names
    1. GS-5745
    type
    DRUG
  2. arm Group Labels
    1. Part B: PAC, ADX 800 mg
    description
    Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
    name
    Gemcitabine
    type
    DRUG
  3. arm Group Labels
    1. Part B: PAC, ADX 800 mg
    description
    Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
    name
    Nab-paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. Part B: LAC, ADX 1200 mg
    2. Part B: LSC, ADX 1200 mg
    description
    Administered intravenously on Day 1 of each 21-day treatment cycle
    name
    Carboplatin
    type
    DRUG
  5. arm Group Labels
    1. Part B: LAC, ADX 1200 mg
    description
    Administered intravenously on Day 1 of each 21-day treatment cycle
    name
    Pemetrexed
    type
    DRUG
  6. arm Group Labels
    1. Part B: EGC, ADX 800 mg
    2. Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    3. Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    4. Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    5. Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
    name
    Leucovorin
    type
    DRUG
  7. arm Group Labels
    1. Part B: EGC, ADX 800 mg
    2. Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    3. Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
    name
    Oxaliplatin
    type
    DRUG
  8. arm Group Labels
    1. Part B: EGC, ADX 800 mg
    2. Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    3. Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    4. Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    5. Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
    name
    5-FU
    type
    DRUG
  9. arm Group Labels
    1. Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
    2. Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
    3. Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    4. Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
    name
    Bevacizumab
    type
    DRUG
  10. arm Group Labels
    1. Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
    2. Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
    description
    Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
    name
    Irinotecan
    type
    DRUG
  11. arm Group Labels
    1. Part B: BRCA, ADX 800 mg
    2. Part B: LSC, ADX 1200 mg
    description
    Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)
    name
    Paclitaxel
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
236
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events
    time Frame
    Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
  2. description
    Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
    measure
    Percentage of Participants Experiencing Laboratory Abnormalities
    time Frame
    Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Full study description
brief Summary
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Source references
references
  1. citation
    Shah MA, Starodub A, Sharma S, Berlin J, Patel M, Wainberg ZA, Chaves J, Gordon M, Windsor K, Brachmann CB, Huang X, Vosganian G, Maltzman JD, Smith V, Silverman JA, Lenz HJ, Bendell JC. Andecaliximab/GS-5745 Alone and Combined with mFOLFOX6 in Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: Results from a Phase I Study. Clin Cancer Res. 2018 Aug 15;24(16):3829-3837. doi: 10.1158/1078-0432.CCR-17-2469. Epub 2018 Apr 24.
    pmid
    29691300
    type
    RESULT
  2. citation
    Lenz H, Park H, Shah MA, Berlin JD, Bruetman D, Chaves J, et al. Results of a phase I study of andecaliximab in combination with mFOLFOX6 and bevacizumab in patients with previously untreated metastatic colorectal cancer. Annals of Oncology (2018) 29 (suppl_8): viii150-viii204
    type
    RESULT
  3. citation
    Wainberg Z, Bendell J, Lenz H, Baron A, Berlin J, Bessudo A, et al. Results from a phase I study of andecaliximab in combination with FOLFIRI and bevacizumab in patients with second line metastatic colorectal cancer. Journal of Clinical Oncology 36, no. 15_suppl (May 20, 2018) 3578-3578
    type
    RESULT
  4. citation
    Bendell J, Patel M, Brachmann C, Huang X, Maltzman J, Smith V, et al. Updated results of a phase 1 study combining the matrix metalloproteinase 9 inhibitor GS-5745 with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer [Abstract 363] 2017 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
    type
    RESULT
  5. citation
    Brachmann C, Zhang Y, Zavodovskaya M, Hu J, Maltzman J, Smith V, et al. Evaluating collagen neoepitopes as pharmacodynamic biomarkers of GS-5745, an MMP9 inhibitor, in advanced gastric cancer [Abstract 58] 2017 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
    type
    RESULT
  6. citation
    Juric V, Mikels-Vigdal A, O'Sullivan C, Greenstein A, Stefanutti E, Barry-Hamilton V, et al. Inhibition of MMP9 improves anti-tumor immunity by changing the tumor microenvironment to promote T cell trafficking and activation. [Abstract 653/27]. 2017 American Association for Cancer Research Annual Meeting 110th Annual Meeting; 2017 01 April-05 April; Washington, DC
    type
    RESULT
  7. citation
    Zavodovskaya M, Zhang Y, Xiao Y, Maltzman J, Smith V, Brachmann C, et al. Exploratory Serum Biomarker Analysis in Gastric Cancer Patients Treated with GS-5745, an MMP9 Inhibitor, in Combination with mFOLFOX6 [Abstract 4463/24]. 2017 American Association for Cancer Research Annual Meeting 110th Annual Meeting; 2017 01 April-05 April; Washington, DC
    type
    RESULT
  8. citation
    Bendell J, Huang X, Smith V, Maltzman J, Starodub A. Results of a phase I study of GS-5745 in combination with gemcitabine and nab-paclitaxel in patients (pts) with advanced pancreatic cancer [abstract e15683] 2016. J Clin Oncol 34 supplemental
    type
    RESULT
  9. citation
    Shah M, Starodub A, Wainberg Z, Smith V, Maltzman J, Bendell J. Results of a phase I study of GS-5745 in combination with mFOLFOX in patients with advanced unresectable gastric / GE junction tumors [Poster 4033]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 03 June- 07 June; Chicago, IL
    type
    RESULT
  10. citation
    Bendell J, Starodub A, Sharma S, Wainberg Z, Shah M, Thai D. Phase I Study of GS-5745 Alone and in Combination with Chemotherapy in Patients with Advanced Solid Tumors [Poster 4030]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May-02 June; Chicago, IL
    type
    RESULT
  11. citation
    Marshall DC, Lyman SK, McCauley S, Kovalenko M, Spangler R, Liu C, Lee M, O'Sullivan C, Barry-Hamilton V, Ghermazien H, Mikels-Vigdal A, Garcia CA, Jorgensen B, Velayo AC, Wang R, Adamkewicz JI, Smith V. Selective Allosteric Inhibition of MMP9 Is Efficacious in Preclinical Models of Ulcerative Colitis and Colorectal Cancer. PLoS One. 2015 May 11;10(5):e0127063. doi: 10.1371/journal.pone.0127063. eCollection 2015.
    pmid
    25961845
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice