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Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

ConditionsHead and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-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 CarcinomaTriple Negative Breast Cancer (TNBC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

230 Participants
are divided into 4 treatment groups
Group A: Phase 1: Dose Escalation MonotherapyExperimental treatment 1 intervention
Group B: Phase 1: Dose Escalation Combination TherapyExperimental treatment 2 interventions
Group C: Phase 2: Dose Expansion MonotherapyExperimental treatment 1 intervention
Group D: Phase 2: Dose Expansion Combination TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Up to 2 years
2

Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame
Up to 28 days
3

Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
Up to 2 years

Secondary outcomes

1

Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
Up to 2 years
2

Maximum Plasma Concentration (Cmax) of GTAEXS617

Time frame
Predose up to 24 hours postdose
3

Time Maximum Plasma Concentration (Tmax) of GTAEXS617

Time frame
Predose up to 24 hours postdose
4

Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617

Time frame
Predose up to 24 hours postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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