BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

ClinicalTrials.gov ID

NCT06120283

Acronym / sponsor ID

BGB-43395-101

Conditions

Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast

Keywords

breast cancer, advanced solid tumor, advanced breast cancer, hormone receptor positive breast cancer, HER2-negative breast cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, BGB-43395

Phase

Phase 1

Study type

Interventional

Recruitment status

Recruiting

Enrolment

433 participants (estimated)

Lead sponsor

BeOne MedicinesIndustry (pharma, biotech, devices)

Study start

1 Dec 2023 (actual)

Primary completion

Dec 2029 (estimated)

Study completion

Dec 2029 (estimated)

First posted

7 Nov 2023 (actual)

Results

Not posted in the source record

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

5

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. Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

   Time frame: Up to approximately 60 months

   Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.

2. Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395

   Time frame: Up to approximately 60 months

   MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached.

3. Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395

   Time frame: Up to approximately 60 months

   RDFE of BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant will be determined based upon the MTD or MAD.

4. Phase 1b: Objective Response Rate (ORR)

   Time frame: Up to approximately 60 months

   ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
• Individual participant dataSharing planned: Yes. BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Related trials for Advanced Solid Tumor

• 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

• Active, not recruitingPhase 1

  A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor

  Neoplasms

• 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

• Active, not recruitingPhase 2

  Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)

  Advanced Lymphoma, Advanced Malignant Solid Neoplasm

• RecruitingPhase 1/2

  Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer

  Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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.

61 sites in 11 countries: see every site and its status.