A phase 1/2 open-label, multicenter study to assess the safety, pharmacokinetics and anti-tumor activity of GTAEXS617 in patients with advanced solid tumors

Phase 1

Recruiting

• Conditions: Advanced solid tumors; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10006204Term: Breast carcinoma Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10052360Term: Colorectal adenocarcinoma Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508227-13-00
• Lead Sponsor: Exscientia AI Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

1. Aged =18 years at the time of signing the informed consent., 10. A nonsterilized male participant with female partners of reproductive potential must agree to use contraception during the treatment period and for at least 6 months after the final dose of the study treatment and must refrain from donating sperm during this period. Acceptable methods of contraception are defined in Appendix 2 of the protocol., 11. Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases, as confirmed by a radiologist, if appropriate, and as deemed safe by the Investigator., 2. Able and willing to provide written informed consent prior to start of any study-specific procedures., 3. ECOG performance status 0-1., 4. Estimated life expectancy >3 months., 5. Ability to swallow and retain oral medication., 6. One the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma., 7. Patients must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SOC treatments. Patients who have not previously received SOC agents/regimens may be eligible for study participation if the patient is either unable to tolerate or deemed not a suitable candidate for standard therapy., 8. Adequate hematological, liver, and renal function defined below (repeated measurements of borderline values are permitted once): o Hemoglobin =8.5 g/dL. Any red blood count transfusion must have occurred at least 28 days prior to Screening. o Absolute neutrophil count =1.5 × 109/L. Any granulocyte colonystimulating factor transfusion must have occurred at least 21 days prior to Screening. o Platelet count =100 × 109/L. Any platelet transfusion must have occurred at least 7 days prior to Screening. o Total bilirubin =1.5 institutional ULN, (or where =2 × ULN with known hepatobiliary metastases or =3 × ULN if known Gilbert's syndrome). o ALT or AST =3 × ULN (or =5 × ULN if liver metastases are present). o Serum creatinine <1.5 × ULN., 9. Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: o Not a woman of childbearing potential (WOCBP) (as defined in Appendix 2 of the protocol). OR o A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 of the protocol during the treatment period and for at least 6 months after the final dose of study treatment.

Exclusion Criteria

1. Any medical or psychiatric condition that, in the view of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study and make them unsuitable for participation., 10. Received medications known to prolong QTc within 5 half-lives before the first dose of the study treatment. List of medications that prolong QTc can be obtained from crediblemeds.org., 11. QTcF >480 msec (average obtained from 3 ECGs) or history of torsades de pointes or history of congenital long QT syndrome. Patients with an apparent prolonged QT due to bundle branch block may be eligible on discussion with the Sponsor., 12. Administration of a live vaccine within 28 days of starting study treatment and for up to 1 month after the final dose of study treatment or anticipation that such vaccine will be required during the study. Note: mRNA-based vaccines for COVID-19 are allowed as well as inactivated flu vaccines., 13. Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment., 14. Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives of the CYP3A modulator (whichever is longer) before the first dose of study treatment. Participants who have received moderate CYP3A inhibitors or inducers may be accepted onto the study at the discretion of the Investigator and on agreement with the Sponsor., 15. Participants who have 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 of the drug (whichever is shorter) before the first dose of study treatment may be allowed at the discretion of the Investigator and on agreement with the Sponsor., 16. Participants who have received treatment with known substrates of organic anion transporting peptide 1B3 (OATP1B3) or BCRP within 14 days or 5 half-lives of the drug (whichever is longer) before the first dose of study treatment may be allowed on a case-by-case basis based on individual benefit subject/risk at the discretion of the investigation and on agreement with the Sponsor., 17. Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, ie, =Grade 2 per NCI CTCAE v5.0 except fatigue, alopecia, infertility, or those relating to palliative radiotherapy within 6 weeks prior to first dose of study treatment., 18. Current enrollment in another clinical study unless it is non-interventional or the follow-up period of an interventional study., 19. Has had or is scheduled to have major surgery <28 days prior to the first dose of study treatment., 2. Known hypersensitivity to any components of the study treatment or comparable drugs (drugs targeting CDK7)., 20. Active bleeding diathesis., 21. International normalized ratio =1.5., 3. Active and clinically significant (CS) infection requiring systemic antibacterial, antiviral, or antifungal therapy =7 days of the first scheduled dose of the study treatment., 4. Known active infections with hepatitis B, hepatitis C, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness., 5. Refractory nausea and/or vomiting, c

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified