Phase 1 Head and Neck Cancer Trial, Recruiting NCT07274852 Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. Condition: Head and Neck Cancer
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Phase 1 Head and Neck Cancer Trial, Recruiting

NCT07274852
Recruiting Phase 1

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:

  • People who are willing to sign a consent form and follow the study requirements
  • People of any gender
  • People aged 18 to 75 years (for the Phase Ia part of the study) or aged 18 and older (for the Phase Ib part)
  • People with a life expectancy of at least 3 months
  • People who have a solid tumour that has spread locally or to other parts of the body, confirmed by a tissue or cell test, and whose cancer has not responded to standard treatments
  • People who can provide a stored or fresh tumour tissue sample from within the past 3 years
  • People who have at least one tumour that can be measured using standard imaging guidelines (confirm with trial site)
  • People who are generally well enough to carry out daily activities, based on a standard physical fitness score of 0 or 1 (confirm with trial site)
  • People whose side effects from previous cancer treatments have mostly resolved to a mild level
  • People with healthy heart function, with the heart pumping at least 50% of its capacity
  • People whose liver, kidney, and other organ functions meet the required levels (confirm with trial site for specific values)
  • People with normal blood clotting results within accepted ranges (confirm with trial site for specific values)
  • People with low or no protein detected in their urine
  • Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study, must not be breastfeeding, and all participants regardless of gender must use effective barrier contraception during the study and for 6 months after it ends

Who may not be able to join:

  • People who have had chemotherapy, biological therapy, or immunotherapy within the 4 weeks (or 5 half-lives of the drug) before starting the trial
  • People with a history of serious heart disease
  • People with certain heart rhythm abnormalities, including prolonged QT interval, complete left bundle branch block, or third-degree heart block (confirm with trial site)
  • People with currently active autoimmune or inflammatory conditions
  • People diagnosed with another cancer within the past 5 years
  • People with high blood pressure that remains poorly controlled even while taking two blood pressure medications
  • People with a history of a lung condition called interstitial lung disease that required steroid treatment, currently active interstitial lung disease, or significant radiation-related lung inflammation
  • People with active symptoms from cancer that has spread to the brain or spinal cord
  • People with a known allergy to certain types of antibody-based medicines or to any ingredient in the trial drug (confirm with trial site)
  • People who have previously had an organ transplant or a stem cell transplant from a donor
  • People who have received a high cumulative dose of a type of chemotherapy called anthracyclines in previous treatment (confirm with trial site for the specific threshold)
  • People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C infection
  • People with a current serious infection that requires treatment throughout the body, such as severe pneumonia or blood infection
  • People who have taken part in another clinical trial within the 4 weeks before starting this one
  • Women who are pregnant or breastfeeding
  • People who the trial doctors consider unsuitable for other reasons not listed above

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 23 July 2026
Phase 1: approximately ~10% 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 1
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
10 December 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Phase Ia: Dose limiting toxicity (DLT); Phase Ia: Maximum tolerated dose (MTD); Phase Ib: Recommended Phase II Dose (RP2D)

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: 23 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