NCT04306900 · REGISTRY CONDITION SEARCH

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

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: 2025-07-29

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

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

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

→

outcome · POSTED

The Incident of Adverse Events

→

outcome · POSTED

Confirmed Objective Response Rate (ORR)

→

outcome · POSTED

Best Response (BOR)

→

outcome · POSTED

Duration of Response (DOR)

→

outcome · POSTED

Disease Control Rate (DCR)

→

outcome · POSTED

Progression-free Survival (PFS)

→

outcome · POSTED

Overall Survival (OS)

→

outcome · POSTED

Pharmacokinetics (PK)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Abbreviated Inclusion Criteria: 1. Age 18 years or older, is willing and able to provide informed consent 2. Histologically confirmed diagnosis of unresectable or metastatic solid tumor malignancy in selected tumor types 3. Life expectancy \> 12 weeks 4. ECOG performance status of 0-1 Abbreviated Exclusion Criteria: 1. History of allergy or hypersensitivity to study treatment components. Patients with a history of severe hypersensitivity reaction to any monoclonal antibody. 2. Use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment
healthy Volunteers: false
maximum Age: 110 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
TTX-030 plus budigalimab plus mFOLFOX6
intervention Names
Combination Product: TTX-030, budigalimab and mFOLFOX6
label
Combo 1
type
EXPERIMENTAL
description
TTX-030 plus budigalimab plus docetaxel
intervention Names
Combination Product: TTX-030, budigalimab and docetaxel
label
Combo 2
type
EXPERIMENTAL
description
TTX-030 plus mFOLFOX6
intervention Names
Combination Product: TTX-030 and mFOLFOX6
label
Combo 3
type
EXPERIMENTAL
description
TTX-030 plus pembrolizumab
intervention Names
Combination Product: TTX-030 and pembrolizumab
label
Combo 4
type
EXPERIMENTAL
description
TTX-030 plus budigalimab (selected tumors evaluated in expansion)
intervention Names
Combination Product: TTX-030 and budigalimab
label
Combo 5
type
EXPERIMENTAL
description
TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
intervention Names
Combination Product: TTX-030, budigalimab, nab-paclitaxel and gemcitabine
label
Combo 6
type
EXPERIMENTAL
description
TTX-030 plus nab-paclitaxel + gemcitabine
intervention Names
Combination Product: TTX-030, nab-paclitaxel and gemcitabine
label
Combo 7
type
EXPERIMENTAL
description
Budigalimab plus mFOLFOX6
intervention Names
Combination Product: Budigalimab and mFOLFOX6
label
Combo 8
type
EXPERIMENTAL

interventions

arm Group Labels
Combo 1
description
Dose and schedule per protocol
name
TTX-030, budigalimab and mFOLFOX6
type
COMBINATION_PRODUCT
arm Group Labels
Combo 2
description
Dose and schedule per protocol
name
TTX-030, budigalimab and docetaxel
type
COMBINATION_PRODUCT
arm Group Labels
Combo 3
description
Dose and schedule per protocol
name
TTX-030 and mFOLFOX6
type
COMBINATION_PRODUCT
arm Group Labels
Combo 5
description
Dose and schedule per protocol
name
TTX-030 and budigalimab
type
COMBINATION_PRODUCT
arm Group Labels
Combo 6
description
Dose and schedule per protocol
name
TTX-030, budigalimab, nab-paclitaxel and gemcitabine
type
COMBINATION_PRODUCT
arm Group Labels
Combo 4
description
Dose and schedule per protocol
name
TTX-030 and pembrolizumab
type
COMBINATION_PRODUCT
arm Group Labels
Combo 7
description
Dose and schedule per protocol
name
TTX-030, nab-paclitaxel and gemcitabine
type
COMBINATION_PRODUCT
arm Group Labels
Combo 8
description
Dose and schedule per protocol
name
Budigalimab and mFOLFOX6
type
COMBINATION_PRODUCT

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 185
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
A DLT was defined as the occurrence of any of the following toxicities within the DLT Evaluation Period if judged by the Investigator and Sponsor to be possibly, probably, or definitely related to TTX-030 or budigalimab.
measure
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
time Frame
7 day load + 1 cycle (1 cycle is 28 days)
description
Number of study subjects experiencing adverse events (AEs) and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
measure
The Incident of Adverse Events
time Frame
Through study completion, an average of 1 year

secondary Outcomes

description
ORR is defined as the proportion of subjects with CR or PR.
measure
Confirmed Objective Response Rate (ORR)
time Frame
Through study completion, an average of 1 year
description
The BOR was defined as the best response (in the order of CR, PR, stable disease, and PD) by RECIST 1.1 documented from first dose until the end of study, first disease progression, death, or start of new anticancer therapy, whichever was earliest.
measure
Best Response (BOR)
time Frame
Through study completion, an average of 1 year
description
DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
measure
Duration of Response (DOR)
time Frame
Through study completion, an average of 1 year
description
DCR is defined as the proportion of subjects with CR, PR, or SD per RECIST 1.1
measure
Disease Control Rate (DCR)
time Frame
Through study completion, an average of 1 year
description
PFS is measured from documentation of progression or death from any cause, whichever occurs first
measure
Progression-free Survival (PFS)
time Frame
Through study completion, an average of 1 year
description
OS was defined as the time interval from the first dose of study treatment to death from any cause. Participants who were lost to follow-up or survived until the end of the study were censored at the last date that they were known to be alive. Medians, Q1, and Q3 of OS and the proportion of participants who were alive at 3, 6, 9, and 12 months from Study Day 1 were derived using KM methods.
measure
Overall Survival (OS)
time Frame
Through study completion, an average of 1 year
description
Serum concentrations of TTX-030 will be tabulated
measure
Pharmacokinetics (PK)
time Frame
Cycles 1-4 (each cycle is 21-28 days)

Full study description

brief Summary: This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-cf19a3a70cc055896582
requested nct id
NCT04306900
primary nct id
NCT04306900
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
923ea0105799703cd2d32c664904d723a1e3e609f92558b149f00785d6548193
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-cf19a3a70cc055896582
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT04306900
occurrences
context exact
NCT04306900
end
11
exact text
NCT04306900
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/66/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
18bd9f3ed320bc969e8ea3e2f0afce20e579e1fca1897d18f0fb9b14fed71fc5
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Small+Intestine+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice