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GTAEXS617

Phase 1

Head and Neck Squamous Cell Carcinoma (HNSCC) | Small molecule | Oncology |Recursion Pharmaceuticals, Inc.|Last Updated: Aug 13, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

Clinical trial landscape

GTAEXS617 · 1 trial · 6 indications

Phase 1 1
NCT05985655Study to Assess GTAEXS617 in Participants With Advanced Solid TumorsHead and Neck Squamous Cell Carcinoma (HNSCC)
RECRUITING230 Analytics
PHASE1RECRUITING
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to 2 years
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Up to 28 days
Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Up to 2 years

Secondary Endpoints

Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Up to 2 years
Maximum Plasma Concentration (Cmax) of GTAEXS617
Predose up to 24 hours postdose
Time Maximum Plasma Concentration (Tmax) of GTAEXS617
Predose up to 24 hours postdose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1: Dose Escalation MonotherapyEXPERIMENTALParticipants will receive GTAEXS617 oral tablets in increasing doses.
Phase 1: Dose Escalation Combination TherapyEXPERIMENTALParticipants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Phase 2: Dose Expansion MonotherapyEXPERIMENTALParticipants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
Phase 2: Dose Expansion Combination TherapyEXPERIMENTALParticipants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Interventions

NameTypeDescription
GTAEXS617DRUGAdministered as specified in the treatment arm.
SoCDRUGParticipants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months. * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell...

Countries:United StatesBelgiumUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT05985655lastUpdatePostDate: changed
LOWAug 14, 2026NCT05985655lastUpdatePostDate: changed
LOWAug 14, 2026NCT05985655lastUpdatePostDate: changed

Frequently asked questions about GTAEXS617

What is GTAEXS617 used for?

GTAEXS617 is an investigational small molecule being studied for the treatment of advanced solid tumors, including Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC), Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma, and Triple Negative Breast Cancer (TNBC).

Who makes GTAEXS617?

GTAEXS617 is being developed by Recursion Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker RXRX.

What phase is GTAEXS617 in?

GTAEXS617 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. It is currently being evaluated in a Phase 1 study for safety and tolerability in patients with advanced solid tumors.

What clinical trials is GTAEXS617 in?

GTAEXS617 is being studied in a single Phase 1 clinical trial, NCT05985655, titled "Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors." The trial is currently recruiting participants in the United States, Belgium, and the United Kingdom, with a planned enrollment of 230 patients.

How does GTAEXS617 work?

The mechanism of action of GTAEXS617 has not been disclosed in the available information. It is a small molecule being investigated for its potential anti-tumor activity in multiple advanced solid tumor types.