TTX-030 Single Agent And In Combination With Immunotherapy Or Chemotherapy For Patients With Advanced Cancers

Study Overview

TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers

This is a phase 1/1b study of TTX-030, 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, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.

N/A

Solid Tumor
Lymphoma

DRUG: TTX-030
DRUG: Pembrolizumab
DRUG: Gemcitabine
DRUG: nab paclitaxel

TTX-030-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-03-16	Results First Submitted 2024-11-04	Last Update Submitted that met QC Criteria 2025-06-13
First Submitted that Met QC Criteria 2019-03-20	Results First Submitted that Met QC Criteria 2025-06-13	Last Update Posted (ACTUAL) 2025-07-02
First Posted (ACTUAL) 2019-03-21	Results First Posted 2025-07-02	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1, Single Agent TTX-030	DRUG: TTX-030 Variable dose and schedule
EXPERIMENTAL: Arm 2, Anti-PD-1 Combination TTX-030 plus pembrolizumab	DRUG: TTX-030 Variable dose and schedule DRUG: Pembrolizumab Dose and schedule per standard of care
EXPERIMENTAL: Arm 4, Chemotherapy Combination TTX-030 plus gemcitabine plus nab-paclitaxel	DRUG: TTX-030 Variable dose and schedule DRUG: Gemcitabine Dose and schedule per standard of care DRUG: nab paclitaxel Dose and schedule per standard of care

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm 1, Single Agent

TTX-030

DRUG: TTX-030

Variable dose and schedule

EXPERIMENTAL: Arm 2, Anti-PD-1 Combination

TTX-030 plus pembrolizumab

DRUG: TTX-030

Variable dose and schedule

DRUG: Pembrolizumab

Dose and schedule per standard of care

EXPERIMENTAL: Arm 4, Chemotherapy Combination

TTX-030 plus gemcitabine plus nab-paclitaxel

DRUG: TTX-030

Variable dose and schedule

DRUG: Gemcitabine

Dose and schedule per standard of care

DRUG: nab paclitaxel

Dose and schedule per standard of care

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)	A DLT was defined as any clinically significant AE that occurred during Treatment Cycle 1 that the Investigator or Sponsor considered as possibly or likely related to TTX-030 as a single agent, or the combination of TTX-030 and other agent(s), and met the following criteria: NCI CTCAE Version 5.0 Grade 5 event, Grade 4 hematological or Grade≥3 non-hematological toxicities, or Grade≥3 irAEs. Laboratory abnormalities that were asymptomatic and deemed not clinically significant were not regarded as DLTs. During Dose Escalation, each dosing cohort was completed through the DLT observation window before escalation was allowed within its arm. In each Safety Lead-in cohort, all participants were closely monitored for the occurrence of DLTs.	1 cycle (each cycle is 21-28 days)
Objective Response Rate (ORR) - Arm 1 and Arm 2 Expansion Cohorts	Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens	Through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Objective Response Rate (ORR) (Except for Arm 1 and 2 Expansion Cohorts, Where ORR Was a Primary Endpoint)	Anti-tumor activity in subjects treated with TTX-030 as single agent or in combination with specified regimens	Through study completion, an average of 1 year
Maximum Plasma Concentration (Cmax)	PK parameters of serum TTX-030 by Arm and Dose - Cycle 1	Cycles 1-3 (each cycle is 21-28 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

eligible to receive single-agent pembrolizumab as standard of care, or
eligible to receive single-agent docetaxel as standard of care, or
advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care. 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record