Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors

ClinicalTrials.gov ID

NCT03150810

Acronym / sponsor ID

BGB-290-103

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

Ovarian cancer, Triple negative breast cancer, Small cell lung cancer, Gastric cancer, temozolomide, BGB-290, antineoplastic agents, alkylating, alkylating agents,

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

139 participants (actual)

Lead sponsor

BeiGeneIndustry (pharma, biotech, devices)

Collaborators

Myriad Genetics, Inc.

Study start

28 Jun 2017 (actual)

Primary completion

4 May 2023 (actual)

Study completion

4 May 2023 (actual)

First posted

12 May 2017 (actual)

Results

Posted 20 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Sequential

Masking

None (open label)

Number of arms

13

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: From first dose of study drug(s) to 28 days post-dose (up to approximately 1 year and 6 months)

   A DLT is defined as one of the following toxicities occurring during the DLT assessment window: Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting >7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting > 3 days and requiring transfusion, or any decreased platelet count <15,000/mm3/ <15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST)

2. Number of Participants Experiencing Adverse Events (AEs)

   Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months

   Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03

3. Objective Response Rate (ORR)

   Time frame: Up to approximately 5 years and 10 months

   ORR is defined as the percentage of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where BOR is defined as the best response recorded from the first postbaseline tumor assessment until data cutoff date, disease progression or start of new anticancer treatment.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 38970256Stradella A, Johnson M, Goel S, Park H, Lakhani N, Arkenau HT, Galsky MD, Calvo E, Baz V, Moreno V, Saavedra O, Luen SJ, Mu S, Wan Q, Chang V, Zhang W, Barve M. Phase 1b study to assess the safety, tolerability, and clinical activity of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors. Cancer Med. 2024 Jul;13(13):e7385. doi: 10.1002/cam4.7385.
• Individual participant dataSharing planned: Yes

Related trials for Locally Advanced or Metastatic Solid Tumors

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• RecruitingPhase 1/2

  A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

  Locally Advanced Solid Tumor, Metastatic Solid Tumor

• RecruitingPhase 1

  A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors

  Cancer

• Active, not recruitingPhase 1

  A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

  Locally Advanced Solid Tumors, Recurrent Solid Tumors

• RecruitingPhase 1/2

  Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

  High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

22 sites in 4 countries: see every site and its status.