Locally Advanced or Metastatic Pancreatic Cancer WithPhase 1/2NCT07296341
HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
A Phase 1/2 study testing HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine and HRS-4642;nab-paclitaxel; gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer With, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Pancreatic Cancer With
- What is being tested?
- HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine and HRS-4642;nab-paclitaxel; gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to Dec 2027
- Phase
- Phase 1/2
- 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
- Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
- ECOG performance status 0 or 1
- Life expectancy of greater than or equal to 12 weeks.
- Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
- Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
- At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
Who cannot join
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis
- Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
- Subjects known or suspected to have interstitial pneumonia
- According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
- Acute or chronic pancreatitis with significant clinical significance
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
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Yupei Zhao
About this study
Official title: A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
- Being tested
- HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine, HRS-4642;nab-paclitaxel; gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabineDrug
HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
HRS-4642;nab-paclitaxel; gemcitabineDrug
nab-paclitaxel in combination with gemcitabine
| Study group | Role | What they receive |
|---|---|---|
| HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine | Experimental | Not described Receives: Drug: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine |
| nab-paclitaxel in combination with gemcitabine | Active comparator | Not described Receives: Drug: HRS-4642;nab-paclitaxel; gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
Measured: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
Secondary outcomes (4)
Objective response rate (ORR)
Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator.
Measured: up to 10 months following the date the last patient was randomized
disease control rate (DCR)
Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR.
Measured: up to 10 months following the date the last patient was randomized
Duration of response (DoR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1.
Measured: up to 10 months following the date the last patient was randomized
Overall survival (OS)
Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.
Measured: From study start until target OS events have occurred (approximately 20 months after last patient enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Pancreatic Cancer WithStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296341
- Sponsor's protocol ID
- HRS-4642-206
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07296341
- Acronym / sponsor ID
- HRS-4642-206
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (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.
This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine | Experimental | Drug: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine |
| nab-paclitaxel in combination with gemcitabine | Active comparator | Drug: HRS-4642;nab-paclitaxel; gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
- ECOG performance status 0 or 1
- Life expectancy of greater than or equal to 12 weeks.
- Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
- Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
Key exclusion criteria (5 listed)
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis
- Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
- Subjects known or suspected to have interstitial pneumonia
- According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
- Acute or chronic pancreatitis with significant clinical significance
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;Adebrelimab Injection; nab-paclitaxel; gemcitabineHRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine | Drug | HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine |
| HRS-4642;nab-paclitaxel; gemcitabinenab-paclitaxel in combination with gemcitabine | Drug | nab-paclitaxel in combination with gemcitabine |
Primary outcome
Progression free survival (PFS)
Time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
4 secondary outcomes
Objective response rate (ORR)
Time frame: up to 10 months following the date the last patient was randomized
disease control rate (DCR)
Time frame: up to 10 months following the date the last patient was randomized
Duration of response (DoR)
Time frame: up to 10 months following the date the last patient was randomized
Overall survival (OS)
Time frame: From study start until target OS events have occurred (approximately 20 months after last patient enrollment)
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 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine and HRS-4642;nab-paclitaxel; gemcitabine in people with Locally Advanced or Metastatic Pancreatic Cancer With, run by Shanghai Hengrui Pharmaceutical Co., Ltd. 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 6 inclusion and 5 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 14 Jan 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Zengquan Gu (0518-82342973, zengquan.gu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months). 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 14 Jan 2026.