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TTX-030, budigalimab and mFOLFOX6

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |AbbVie Inc.|Last Updated: Jul 29, 2025

Target and mechanism

ModalitySmall molecule

Also known as TTX-030, nab-paclitaxel and gemcitabine

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment185

FDA Designations

No designations recorded

Clinical trial landscape

TTX-030, budigalimab and mFOLFOX6 · 1 trial · 1 indication

Phase 1 1
NCT04306900TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced CancersSolid Tumor, Adult
COMPLETED185 Analytics
PHASE1COMPLETED
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers
Solid Tumor, Adult
NCT04306900185
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Study Endpoints

Primary Endpoints

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
7 day load + 1 cycle (1 cycle is 28 days)

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.

The Incident of Adverse Events
Through study completion, an average of 1 year

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.

Secondary Endpoints

Confirmed Objective Response Rate (ORR)
Through study completion, an average of 1 year
Best Response (BOR)
Through study completion, an average of 1 year
Duration of Response (DOR)
Through study completion, an average of 1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Combo 1EXPERIMENTALTTX-030 plus budigalimab plus mFOLFOX6
Combo 2EXPERIMENTALTTX-030 plus budigalimab plus docetaxel
Combo 3EXPERIMENTALTTX-030 plus mFOLFOX6
Combo 4EXPERIMENTALTTX-030 plus pembrolizumab
Combo 5EXPERIMENTALTTX-030 plus budigalimab (selected tumors evaluated in expansion)
Combo 6EXPERIMENTALTTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine
Combo 7EXPERIMENTALTTX-030 plus nab-paclitaxel + gemcitabine
Combo 8EXPERIMENTALBudigalimab plus mFOLFOX6

Interventions

NameTypeDescription
TTX-030, budigalimab and mFOLFOX6COMBINATION_PRODUCTDose and schedule per protocol
TTX-030, budigalimab and docetaxelCOMBINATION_PRODUCTDose and schedule per protocol
TTX-030 and mFOLFOX6COMBINATION_PRODUCTDose and schedule per protocol
TTX-030 and budigalimabCOMBINATION_PRODUCTDose and schedule per protocol
TTX-030, budigalimab, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCTDose and schedule per protocol
TTX-030 and pembrolizumabCOMBINATION_PRODUCTDose and schedule per protocol
TTX-030, nab-paclitaxel and gemcitabineCOMBINATION_PRODUCTDose and schedule per protocol
Budigalimab and mFOLFOX6COMBINATION_PRODUCTDose and schedule per protocol
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Eligibility Criteria

Age Range18 Years to 110 Years
SexALL
Healthy VolunteersNo
Study Sites32

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 ...

Countries:United StatesSouth Korea
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Frequently asked questions about TTX-030, budigalimab and mFOLFOX6

What is TTX-030 used for?

TTX-030 is an investigational small molecule being studied for the treatment of solid tumors, including pancreatic cancer. It is being evaluated in combination with immunotherapy and/or chemotherapy in adult patients with advanced cancers. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does TTX-030 target?

TTX-030 is a small molecule that targets CD39, an enzyme involved in the adenosine pathway that can suppress immune responses in tumors. By inhibiting CD39, TTX-030 aims to enhance the body's immune system to fight cancer cells. This mechanism is being studied in combination with other therapies for solid tumors.

Who is developing TTX-030?

TTX-030 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of TTX-030 in patients with advanced cancers, including pancreatic cancer.

What phase is TTX-030 in?

TTX-030 is in Phase 1 and Phase 2 clinical trials. A Phase 1 study (NCT04306900) has been completed, and a Phase 2 study (NCT06119217) is active but not recruiting patients. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is TTX-030 in?

TTX-030 has been studied in two clinical trials. NCT04306900 is a completed Phase 1 trial evaluating TTX-030 in combination with immunotherapy and/or chemotherapy in adults with advanced solid tumors. NCT06119217 is an active Phase 2 trial studying TTX-030 with chemotherapy, with or without budigalimab, in patients with pancreatic cancer.

Is TTX-030 the same as budigalimab?

No, TTX-030 and budigalimab are different drugs. TTX-030 is a small molecule targeting CD39, while budigalimab is an immunotherapy agent. They are being studied together in combination with chemotherapy for the treatment of pancreatic cancer, as seen in the Phase 2 trial NCT06119217.