Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Study ID
NCT05985655
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma
  • Non-small Cell Lung Cancer (NSCLC)
  • Pancreatic Adenocarcinoma
  • Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GTAEXS617 — DRUG
    Administered as specified in the treatment arm.
  • SoC — DRUG
    Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Study Details

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Key Dates

Start date
Jul 6, 2023
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
230 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Escalation Monotherapy
    Participants will receive GTAEXS617 oral tablets in increasing doses.
  • Experimental: Phase 1: Dose Escalation Combination Therapy
    Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
  • Experimental: Phase 2: Dose Expansion Monotherapy
    Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
  • Experimental: Phase 2: Dose Expansion Combination Therapy
    Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years ]

Central Contacts

  • Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
    385-374-1724
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90089-
START MidwestGrand RapidsMichigan49546-
START San AntonioSan AntonioTexas78229-
START Mountain RegionWest Valley CityUtah84119-

Find similar trials in Los Angeles, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CASTART Midwest· Grand Rapids, MISTART San Antonio· San Antonio, TXSTART Mountain Region· West Valley City, UT

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