Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies

Phase 1

Active, not recruiting

Conditions: Solid tumors and hamatological malignancies
MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104
MedDRA version: 21.1Level: LLTClassification code: 10066481Term: Hematological malignancy Class: 10029104
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-508883-31-00

Lead Sponsor: Beigene Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 428

Inclusion Criteria

Currently participating in a BeiGene-sponsored eligible parent study, Fulfills treatment criteria specified in the parent study protocol, In the opinion of the investigator, the patient will continue to benefit from and tolerate any of the parent study treatments, The first dose of study treatment in the LTE study will be received within the treatment interruption period allowed by the parent study. Details for treatment-specific requirements can be found in the relevant appendices, Female patients of childbearing potential and female partners of nonsterile males must practice highly effective methods of birth control initiated before the first dose of study treatment, for the duration of the study, and after the last dose of study treatment. See Appendix L for contraception methods. More details on treatment-specific requirements can be found in the relevant appendices., Male patients are eligible if abstinent or vasectomized or if they agree to use contraception for the duration of the study, and after the last dose of study treatment. See Appendix L for contraception methods. Nonsterile males receiving investigational drugs or other genotoxic chemotherapeutic treatment must avoid sperm donation for the duration of the study and after the last dose of study treatment. More details on treatmentspecific requirements can be found in the relevant appendices., A signed informed consent form obtained before enrolling in this LTE study and receiving study treatment

Exclusion Criteria

Permanently discontinued from all investigational drugs in the parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent., Have uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy 14 days before the planned first dose of treatment in the LTE study, Have a life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient's safety, interfere with the absorption or metabolism of investigational drugs, or put the study outcomes at undue risk, Underwent treatment with any systemic anticancer treatment (other than treatment permitted in the parent study) during the time between the last treatment in the parent study and the first dose of study treatment in the LTE study, Pregnant or lactating women, Inability to comply with study procedures, Concurrent participation in another therapeutic clinical trial, Are participating in the follow-up phase in a parent study for which there is no planned survival analysis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of BeiGene investigational drugs in patients with advanced<br>malignancies;Secondary Objective: To evaluate the efficacy of BeiGene investigational drugs by following patients for overall survival;Primary end point(s): Safety as assessed by incidence of all AEs of special interest, Grade 3, 4, or 5 AEs, Grade 2 AEs that affect vital organs (eg, heart, liver, brain, lung, kidney), nonserious AEs that lead to dose modification or drug discontinuation or withdrawal from the trial, and SAEs of any severity.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Overall survival defined as the time from start of treatment in parent study (or randomization date for a randomized study) until the date of death from any cause.