Biliary Tract CancerPhase 2NCT06620848
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
A Phase 2 study testing HRS-4642 monotherapy and HRS-4642 and adebrelimab combination therapy in people with Biliary Tract Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- HRS-4642 monotherapy and HRS-4642 and adebrelimab combination therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old, male or female.
- Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
- Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
- Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- ECOG performance status of 0-1.
- With a life expectancy of ≥3 months.
- Have adequate laboratory parameters and organ functions during the screening period.
Who cannot join
- Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
- Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
- Patients with untreated or active central nervous system tumor metastasis.
- Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200020
Guoming Shi, M.D, shi.guoming@zs-hospital.sh.cn
Guoming Shi, M.D
About this study
Official title: A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.
- Conditions
- Biliary Tract Cancer
- Being tested
- HRS-4642 monotherapy, HRS-4642 and adebrelimab combination therapy
- Keywords
- KRAS G12D, Biliary Tract Cancer
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642 monotherapyDrug
HRS-4642 will be administrated per dose level in which the patients are assigned.
HRS-4642 and adebrelimab combination therapyDrug
HRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned.
| Study group | Role | What they receive |
|---|---|---|
| HRS-4642 monotherapy arm | Experimental | Patients will receive HRS-4642 monotherapy at a fixed dose. Receives: Drug: HRS-4642 monotherapy |
| combination therapy arm | Experimental | Patients will receive HRS-4642 and adebrelimab combination therapy. Receives: Drug: HRS-4642 and adebrelimab combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by RECIST V1.1
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Measured: up 2 years
Adverse events(AEs), serious adverse events（SAEs）
AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late).
Measured: up 2 years
Secondary outcomes (3)
Disease control rate (DCR)
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Measured: up 2 years
Progression-free survival (PFS)
PFS is defined as Time from the date of enrollment to of disease
Measured: up 2 years
Overall survival (OS)
OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: up 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Fan, Shanghai Zhongshan Hospital
- Investigators
- Jia Fan, M.D, Principal investigator, Shanghai Zhongshan HospitalGuoming Shi, M.D, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620848
- Sponsor's protocol ID
- BTC-2nd-IIT-HRS4642-SHR1316
- Status last verified
- Apr 2025
- First submitted
- 26 Sep 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors.
- ClinicalTrials.gov ID
- NCT06620848
- Acronym / sponsor ID
- BTC-2nd-IIT-HRS4642-SHR1316
- Conditions
- Biliary Tract Cancer
- Keywords
- KRAS G12D, Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
The study was designed to evaluate the efficacy and safety of HRS-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-4642 monotherapy arm | Experimental | Drug: HRS-4642 monotherapyPatients will receive HRS-4642 monotherapy at a fixed dose. |
| combination therapy arm | Experimental | Drug: HRS-4642 and adebrelimab combination therapyPatients will receive HRS-4642 and adebrelimab combination therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years old, male or female.
- Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
- Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
- Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- ECOG performance status of 0-1.
Key exclusion criteria (4 listed)
- Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
- Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
- Patients with untreated or active central nervous system tumor metastasis.
- Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-4642 monotherapyHRS-4642 will be administrated per dose level in which the patients are assigned. | Drug | HRS-4642 monotherapy arm |
| HRS-4642 and adebrelimab combination therapyHRS-4642 and adebrelimab will be administrated per dose level in which the patients are assigned. | Drug | combination therapy arm |
Primary outcome
Objective response rate (ORR) by RECIST V1.1
Time frame: up 2 years
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Adverse events(AEs), serious adverse events（SAEs）
Time frame: up 2 years
AEs and SAEs occurred from the first dose of treatment to 30 days after the last dose of HRS-4642 or 90 days after the last dose of adebrelimab (whichever comes late).
3 secondary outcomes
Disease control rate (DCR)
Time frame: up 2 years
Progression-free survival (PFS)
Time frame: up 2 years
Overall survival (OS)
Time frame: up 2 years
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 2 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Jia Fan, M.D principal investigator
Shanghai Zhongshan Hospital
Guoming Shi, M.D principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4642 monotherapy and HRS-4642 and adebrelimab combination therapy in people with Biliary Tract Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoming Shi, M.D (13916969578, shi.guoming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) by RECIST V1.1 (time frame: up 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.