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S095035

Phase 1

MTAP-deleted Solid Tumors | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06188702S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAPPHASE1 ACTIVE NOT_RECRUITING 60 — — Apr 29, 2024May 1, 2027May 26, 202622 United States, Australia +5
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Study Endpoints
Primary Endpoints
Dose limiting toxicities (DLTs)
Through cycle 1 (each cycle is 28 days)

Phase 1 only

Total number of adverse events (AEs)
Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years

Phase 1 only

Total number of serious adverse events (SAEs)
Through the Safety Follow-up Visit (until 30 days after the last dose of study treatment) approximately 5 years

Phase 1 only

Objective response rate (ORR)
Through the end of the study (approximately 5 years)

Phase 2 only; Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 criteria as per the investigator's assessment and by blinded independent central review (BICR)

Secondary Endpoints
Area under the concentration-vs-time curve (AUC) from 0 to time of last measurable concentration (AUC0-t)
Through the last dose of study treatment (approximately 5 years)
AUC from 0 to infinity (AUC0-∞)
Through the last dose of study treatment (approximately 5 years)
AUC over 1 dosing interval at steady state (AUCtau,ss)
Through the last dose of study treatment (approximately 5 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1 Arm 1 - S095035 single-agent dose escalationEXPERIMENTAL -
Phase 1 Arm 2 - S095035-TNG462 combination dose escalationEXPERIMENTAL -
Phase 2 Arm 1a NSCLC - S095035 single-agent dose expansionEXPERIMENTALNon-Small Cell Lung Cancer
Phase 2 Arm 1b BTC - S095035 single-agent dose expansionEXPERIMENTALBiliary Tract Cancer
Phase 2 Arm 1c PDAC - S095035 single-agent dose expansionEXPERIMENTALPancreatic Ductal Adenocarcinoma
Phase 2 Arm 1d Basket arm - S095035 single-agent dose expansionEXPERIMENTAL -
Phase 2 Arm 2a BTC - S095035-TNG462 combination dose expansionEXPERIMENTALBiliary Tract Cancer
Phase 2 Arm 2b Gastroesophageal - S095035-TNG462 combination dose expansionEXPERIMENTAL -
Phase 2 Arm 2c PDAC - S095035-TNG462 combination dose expansionEXPERIMENTALPancreatic Ductal Adenocarcinoma
Interventions
NameTypeDescription
S095035DRUGS095035 will be taken orally every day in 28-day cycles.
TNG462DRUGTNG462 will be taken orally every day in 28-day cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Estimated life expectancy ≥3 months. * ECOG PS 0-1 * Participants able to comply with highly effective method of birth control requirements. * Participants with histologically confirmed advanced or metastatic solid tumor's (excluding central nervous system tumors other than ID...

Countries:United StatesAustraliaFranceGermanyItalyJapanSpain
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Recent Changes (Last 90 Days)
HIGHMay 27, 2026NCT06188702Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHMay 27, 2026NCT06188702Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06188702primaryCompletionDate: changed
LOWMay 24, 2026NCT06188702studyFirstPostDate: changed