NCT04068896 · REGISTRY CONDITION SEARCH

Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy

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

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2025-05-29

Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).

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

→

baseline

Baseline characteristics

→

outcome · POSTED

To Determine the Safety and Tolerability of NGM120 in Subjects

→

outcome · POSTED

To Determine the Safety and Tolerability of NGM120

→

outcome · POSTED

To Determine the Safety and Tolerability of NGM120

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria (Part 1 and 2): 1. Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line. 2. Have not received any approved chemotherapy, except in the adjuvant setting. 3. Life expectancy of at least 12 weeks 4. Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period. 5. Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible. Inclusion Criteria (Part 3 Prostate Cancer): 1. Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening. 2. Effective castration with serum testosterone levels \<0.5 ng/mL (50 ng/dL; 1.7 nmol/L). 3. Have serum GDF15 levels ≥1300 pg/mL. 4. Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy. 5. Have had PSA doubling time of \>3 months. Exclusion Criteria (All parts): 1. Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication. 2. Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation. 3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment. 4. Subject has documented immunodeficiency or organ transplant. 5. Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression. 6. Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure \> New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation \>470 msec, clinically significant pericardial effusion. 7. Subject has a history or presence of documented inflammatory bowel disease. 8. Subject is known to be positive for human immunodeficiency virus (HIV) infection.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
NGM120 30mg Subcutaneous Injection
intervention Names
Biological: NGM120 30mg
label
Part 1 NGM120 30mg
type
EXPERIMENTAL
description
NGM120 100mg Subcutaneous Injection
intervention Names
Biological: NGM120 100mg
label
Part 1 NGM120 100mg
type
EXPERIMENTAL
description
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
intervention Names
Biological: NGM120 30mg with Gemcitabine and Abraxane
label
Part 2 NGM120 30mg
type
EXPERIMENTAL
description
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
intervention Names
Biological: NGM120 100mg with Gemcitabine and Abraxane
label
Part 2 NGM120 100mg
type
EXPERIMENTAL
description
NGM120 100mg Subcutaneous Injection NGM120 100mg Subcutaneous Injection every 3 weeks
intervention Names
Biological: NGM120 100mg Q3W
label
Part 3 NGM120 100mg Q3W
type
EXPERIMENTAL
description
Placebo together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
intervention Names
Other: Placebo
label
Part 2 Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Part 1 NGM120 30mg
description
NGM120 30mg Subcutaneous Injection
name
NGM120 30mg
type
BIOLOGICAL
arm Group Labels
Part 1 NGM120 100mg
description
NGM120 100mg Subcutaneous Injection
name
NGM120 100mg
type
BIOLOGICAL
arm Group Labels
Part 2 NGM120 30mg
description
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
name
NGM120 30mg with Gemcitabine and Abraxane
type
BIOLOGICAL
arm Group Labels
Part 2 NGM120 100mg
description
NGM120 100 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
name
NGM120 100mg with Gemcitabine and Abraxane
type
BIOLOGICAL
arm Group Labels
Part 3 NGM120 100mg Q3W
description
NGM120 100mg Subcutaneous Injection every 3 weeks
name
NGM120 100mg Q3W
type
BIOLOGICAL
arm Group Labels
Part 2 Placebo
description
Placebo
name
Placebo
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

SEQUENTIAL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 89
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
measure
To Determine the Safety and Tolerability of NGM120 in Subjects
time Frame
From enrollment to end of treatment up to 24 months
description
Discontinuation of investigational product due to toxicity
measure
To Determine the Safety and Tolerability of NGM120
time Frame
From enrollment to end of treatment up to 24 months
description
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
measure
To Determine the Safety and Tolerability of NGM120
time Frame
From enrollment to end of treatment up to 24 months

Full study description

brief Summary: Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).
detailed Description: The aim of the study is to evaluate the safety and tolerability of NGM120 monotherapy in subjects with select advanced solid tumors (Part 1), NGM120 in combination with gemcitabine and Abraxane for the management of metastatic pancreatic cancer (Part 2), and NGM120 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed under 1 or more lines of ADT (Part 3), for up to 24 months of treatment.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-1d5c2b7fbdee2acd2f1a
requested nct id
NCT04068896
primary nct id
NCT04068896
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
payload sha256
a55dd8c5949cb2d3cb48225b6cd4b4a0e8b0e267ab3d56b806e7c320eb1ac861
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-1d5c2b7fbdee2acd2f1a
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT04068896
occurrences
context exact
NCT04068896
end
11
exact text
NCT04068896
start
0
offset unit
unicode_code_points
query cond
Small Intestine Cancer
query disease state id
ds-small-intestine-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
source file sha256
69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
source json pointer
/studies/119/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
bfbd7805ab83fd624c72cab045dbfdbad2197dd09386b8d272c85b426be3c76f
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-8e5eb7120fb8909b45d9
requested nct id
NCT04068896
primary nct id
NCT04068896
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
payload sha256
365b5c75d6a185d91e6b9374ca5e1d31594fd1ef33f410f9bba5ed69b89059d7
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-8e5eb7120fb8909b45d9
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT04068896
occurrences
context exact
NCT04068896
end
11
exact text
NCT04068896
start
0
offset unit
unicode_code_points
query cond
Ovarian Germ Cell Tumors
query disease state id
ds-ovarian-germ-cell-tumors
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
source file sha256
359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
source json pointer
/studies/75/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
bfbd7805ab83fd624c72cab045dbfdbad2197dd09386b8d272c85b426be3c76f
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Ovarian+Germ+Cell+Tumors&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice