A study to investigate the effects of study drug RLY-4008 in patients with Intrahepatic Cholangiocarcinoma and other Advanced Solid Tumors

Phase 1

Conditions: nresectable or metastatic cholangiocarcinoma (CCA), other advanced solid tumors with an FGFR2-alteration or other potential FGFR2-dependent tumors
MedDRA version: 27.0Level: LLTClassification code 10073077Term: Intrahepatic cholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 27.0Level: LLTClassification code 10008595Term: Cholangiocarcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.0Level: LLTClassification code 10014735Term: Endometrial cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.0Level: LLTClassification code 10017760Term: Gastric cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0Level: LLTClassification code 10006192Term: Breast cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-004535-24-SE

Lead Sponsor: Relay Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 550

Inclusion Criteria

Main inclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.2).

Part 4
14. Patient is currently receiving RLY-4008 on RLY-4008-101 Study and benefiting from treatment as assessed by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 363
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 187

Exclusion Criteria

Main exclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.3).

Part 4
21. Patient has permanently discontinued treatment with RLY-4008 for any reason before enrolling into Part 4.