Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Purpose

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.

Conditions

  • 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
  • Triple Negative Breast Cancer (TNBC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 lung cancer (NSCLC), breast carcinoma (hormone receptor-positive [HR+] and Human Epidermal Growth Receptor 2 negative [HER2-] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 [CDK6] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC). - Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments. - Adequate hematological, liver, and renal function. - Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Exclusion Criteria

  • Active and clinically significant (CS) infection. - Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617. - Symptomatic central nervous system (CNS) malignancy or metastases. - Concurrent active or previous malignancy. - Prior organ or allogeneic stem-cell transplantation. - Moderate or severe cardiovascular disease. - Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment. - Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment. - Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment. - Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment. - Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy - Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment. Note: Other protocol Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Dose Escalation Monotherapy 		Participants will receive GTAEXS617 oral tablets in increasing doses.
  • Drug: GTAEXS617
    Administered as specified in the treatment arm.
    Other names:
    • REC-617
Experimental
Phase 1: Dose Escalation Combination Therapy 		Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
  • Drug: GTAEXS617
    Administered as specified in the treatment arm.
    Other names:
    • REC-617
  • Drug: SoC
    Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Experimental
Phase 2: Dose Expansion Monotherapy 		Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
  • Drug: GTAEXS617
    Administered as specified in the treatment arm.
    Other names:
    • REC-617
Experimental
Phase 2: Dose Expansion Combination Therapy 		Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
  • Drug: GTAEXS617
    Administered as specified in the treatment arm.
    Other names:
    • REC-617
  • Drug: SoC
    Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Recruiting Locations

START Midwest
Grand Rapids 4994358, Michigan 5001836 49546

START San Antonio
San Antonio 4726206, Texas 4736286 78229

START Mountain Region
West Valley City 5784607, Utah 5549030 84119

More Details

Status
Recruiting
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Study Contact

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
385-374-1724
clinicaltrials@recursionpharma.com