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S095029

Phase 1

MSI-H/dMMR Gastroesophageal-junction Cancer | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: Apr 3, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

S095029 · 1 trial · 2 indications

Phase 1 1
NCT06116136A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.MSI-H/dMMR Gastroesophageal-junction Cancer
ACTIVE NOT_RECRUITING48 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.
MSI-H/dMMR Gastroesophageal-junction CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Dose-Limiting Toxicities (DLTs)
At the end of Cycle 1 (each cycle is 21 days)

Phase 1b and Phase 2

Total Number of Adverse Events (AEs)
From screening to 90 days after the last dose

Phase 1b and Phase 2

Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
From screening to 90 days after the last dose

Phase 1b and Phase 2

Adverse Events (AEs) Leading to Dose Discontinuation
From screening to 90 days after the last dose

Phase 1b and Phase 2

Objective Response Rate (ORR)
Approximately 2 years

Phase 2 ONLY. The Proportion of participants who achieve complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Endpoints

Duration of Response (DoR)
Approximately 2 years
Progression-Free Survival (PFS)
Approximately 2 years
Disease Control Rate (DCR)
Approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
S095029 and pembrolizumabEXPERIMENTALParticipants diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJ), not previously treated with checkpoint inhibitors (CPIs) may first be enrolled into a Phase 1b safety lead-in part which will be used to identify the recommended Phase 2 dose (RP2D) of S095029 in combination with pembrolizumab. During the Phase 2 part, participants will receive the recommended Phase 2 dose (RP2D) of S095029, along with pembrolizumab.

Interventions

NameTypeDescription
S095029DRUGParticipants will be treated with S095029 via intravenous (IV) infusion every 3 weeks (Q3W).
pembrolizumab 200 mg (KEYTRUDA ®)DRUGParticipants will be treated with 200 mg of pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Have a confirmed diagnosis of locally advanced and unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma * Participants' tumor must have an MSI-H/dMMR status according to institutional guidelines and/or according to the College of American Pathologist...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaDenmarkFranceHungaryItalyJapanPuerto RicoSpainUnited Kingdom
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Frequently asked questions about S095029

What is S095029 used for?

S095029 is an investigational small molecule being studied for the treatment of MSI-H/dMMR gastroesophageal-junction cancer and MSI-H/dMMR gastric cancer. It is currently in Phase 1 clinical development as part of a combination therapy for advanced gastroesophageal junction and gastric cancers.

Who makes S095029?

S095029 is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting a Phase 1 clinical trial to evaluate the safety and activity of S095029 as part of combination therapy in advanced gastroesophageal junction and gastric cancers.

What phase is S095029 in?

S095029 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 48 patients.

What clinical trials is S095029 in?

S095029 is being evaluated in a single Phase 1 clinical trial, NCT06116136, titled "A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers." The trial is active but not recruiting and is enrolling patients with MSI-H/dMMR gastroesophageal-junction or gastric cancer.

Is S095029 the same as any other drug?

No alternative names for S095029 have been disclosed. The drug is identified solely by its code name S095029 in clinical trial records and is being developed by Tango Therapeutics for the treatment of MSI-H/dMMR gastroesophageal-junction and gastric cancers.