Image

Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Recruiting
18 years of age
Both
Phase 1

Powered by AI

Overview

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with tislelizumab in participants with advanced solid tumors. Participants will receive study drug(s) until progressive disease, unacceptable toxicity, withdrawal of consent, death, or another discontinuation criterion is met, whichever occurs first. The maximum length of receiving study drug(s) for a participant is up to 2 years.

Eligibility

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
  4. ≥ 1 measurable lesion per RECIST v1.1.
  5. Able to provide an archived tumor tissue sample.
  6. Adequate organ function.
  7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
  8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).

Exclusion Criteria:

  1. Prior treatment with a B7H4-targeting antibody drug conjugates (ADC)
  2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
  5. Uncontrolled diabetes.
  6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study details

Advanced Solid Tumor

NCT06233942

BeiGene

15 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.