Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors (ELUCIDATE)

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

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer (NSCLC); 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; Pancreatic Adenocarcinoma; Advanced Solid Tumor; Breast Carcinoma; Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatments: Drug: GTAEXS617; Drug: SoC

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05985655

GTAEXS617-001

Details and patient eligibility

About

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617-001 in participants with advanced solid tumors.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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 Cluster of Differentiation 4 [CD4] / Cyclin-Dependent Kinase 6 [CDK6] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC).
• 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.

Key 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 1B3 (OATP1B3) 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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165 participants in 4 patient groups

Phase 1: Dose Escalation Monotherapy

Experimental group

Description:

Participants will receive GTAEXS617 oral tablets in increasing doses.

Treatment:

Drug: GTAEXS617

Phase 1: Dose Escalation Combination Therapy

Experimental group

Description:

Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.

Treatment:

Drug: SoC

Drug: GTAEXS617

Phase 2: Dose Expansion Monotherapy

Experimental group

Description:

Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).

Treatment:

Drug: GTAEXS617

Phase 2: Dose Expansion Combination Therapy

Experimental group

Description:

Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

Treatment:

Drug: SoC

Drug: GTAEXS617