Phase 2 Kidney Cancer Trial, Recruiting NCT06962787 Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT06962787
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to take part and have signed a consent form agreeing to participate
  • You are between 18 and 75 years old (male or female)
  • Your doctors expect you to live for at least 3 more months
  • You are generally active and able to care for yourself, with little or no limitation in daily activities (confirm with trial site)
  • You have been diagnosed with kidney cancer that has spread locally or to other parts of the body, confirmed by a tissue or cell test
  • You are willing to provide a stored or fresh tumor tissue sample taken within the last 3 years
  • You have at least one area of cancer that can be measured on a scan, according to standard criteria
  • Your organs (such as kidneys, liver, and heart) are functioning well enough to meet the study's requirements (confirm with trial site)
  • Any side effects from previous cancer treatments have mostly resolved or are very mild
  • If you are able to have children, you must be willing to use highly effective birth control during the study and for 7 months after your first dose, and women must have a negative pregnancy test within 7 days before starting

Who may not be able to join:

  • You have had chemotherapy, biological therapy, or other cancer treatments within the past 4 weeks (or within 5 half-lives of the drug), or certain specific chemotherapy drugs within the past 6 weeks
  • You have previously been treated with a type of targeted drug (called an ADC) that uses a camptothecin-based substance
  • You have taken immune-modifying drugs within 14 days before starting the trial
  • You have had a serious heart or stroke-related condition in the past 6 months
  • You have certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or uncontrolled irregular heartbeat
  • You currently have an active autoimmune or inflammatory disease
  • You need to take steroid or immune-suppressing medications within 2 weeks before starting the trial
  • You have had another type of cancer within the past 5 years
  • You have a history of lung inflammation (ILD) that required steroid treatment, or currently have or are suspected to have lung inflammation
  • You have poorly controlled diabetes or serious diabetes-related complications
  • You have had an unstable blood clot requiring treatment within the past 6 months
  • You have a serious lung disease that significantly affects your breathing
  • Your cancer has actively spread to your brain or spinal cord
  • You have large or symptomatic fluid build-up in the body that is not well controlled
  • You have a known allergy to the study drugs or any of their ingredients
  • You have previously had a stem cell, bone marrow, or organ transplant from another person
  • You are HIV-positive, or have active tuberculosis, active hepatitis B, or active hepatitis C
  • You had a serious infection within 4 weeks before starting, or have a lung infection currently
  • You have taken part in another clinical trial within the past 4 weeks
  • You have a history of serious mental illness or substance abuse that you are unable to stop
  • Scans show the tumor has grown into or around major blood vessels in the chest
  • You have a serious wound, ulcer, or broken bone that has not healed within the past 4 weeks
  • You have had significant bleeding or a strong tendency to bleed within the past 4 weeks
  • You have received or are planning to receive a live vaccine within 28 days before starting the trial
  • You have other serious health problems or test results that the trial doctors feel would make participation unsafe or affect the study results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 15013238943

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
28 July 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR); Recommended Phase II Dose (RP2D); Frequency of Treatment Emergent Adverse Event (TEAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov