Advanced Solid TumorsPhase 1NCT07136558
Evaluation of ICP-B794 in Patients With Advanced Solid Tumors
A Phase 1 study testing ICP-B794 in people with Advanced Solid Tumors, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.
Trial summary
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- ICP-B794
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2030
- Phase
- Phase 1
- 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 ≥18 years and ≤75 years.
- Histologically confirmed other locally advanced or metastatic solid tumors.
- Life expectancy ≥3 months.
- Adequate organs function within 7 days prior to the first dose of ICP-B794
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
- At least one measurable lesion per RECIST V1.1 criteria.
Show all 12Show fewer
- Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.
- Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.
- WOCBP and male participants must agree to use contraceptive method.
- Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.
- Participants must be able to communicate effectively with investigators and comply with all study requirements.
- Participants voluntarily joined the study and signed the informed concent form (ICF).
Who cannot join
- Other active primary malignancies within 3 years prior to the first dose of investigational product.
- Prior or current treatment with the similar drug or related treatment specified in the protocol.
- Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
- Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
- Major arterial or venous thrombotic events within 3 months prior to first dose.
- Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.
Show all 13Show fewer
- Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.
- Requirement for systemic corticosteroid therapy within 14 days prior to first dose.
- History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction.
- Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.
- Female participants who are pregnant, lactating, or planning pregnancy during the study.
- Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance
- Other conditions determined by the investigator that render patients unsuitable for participation in this study.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Yilong Wu, 13809775415, syylwu@live.cn
About this study
Official title: An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients With Advanced Solid Tumors
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- ICP-B794
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-B794Drug
Intravenous administration once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| ICP-B794 | Experimental | Not described Receives: Drug: ICP-B794 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0
Measured: Up to 2 years
Dose-limiting toxicities (DLT)
Incidence, character, and severity of dose-limiting toxicities.
Measured: Up to 2 years
The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD)
Measured: Up to 2 years
Objective response rate (ORR)
Measured: Up to 2 years
Secondary outcomes (14)
Maximum Plasma Concentration (Cmax)
Measured: Up to 2 years
Time to Maximum Plasma Concentration (Tmax)
Measured: Up to 2 years
Half-life (T1/2)
Measured: Up to 2 years
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Measured: Up to 2 years
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)
Measured: Up to 2 years
Apparent Clearance (CL/F)
Measured: Up to 2 years
Terminal Apparent Volume of Distribution (Vz/F)
Measured: Up to 2 years
Objective Response Rate (ORR)
Measured: Up to 2 years
Disease control rate (DCR)
Measured: Up to 2 years
Duration of response (DOR)
Measured: Up to 2 years
Progression-Free Survival (PFS)
Measured: Up to 2 years
Radiographic progression-free survival (rPFS)
Measured: Up to 2 years
Overall survival (OS)
Measured: Up to 2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B794
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136558
- Sponsor's protocol ID
- ICP-CL-01501
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07136558
- Acronym / sponsor ID
- ICP-CL-01501
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Aug 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.
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-B794 | Experimental | Drug: ICP-B794 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years and ≤75 years.
- Histologically confirmed other locally advanced or metastatic solid tumors.
- Life expectancy ≥3 months.
- Adequate organs function within 7 days prior to the first dose of ICP-B794
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
Key exclusion criteria (13 listed)
- Other active primary malignancies within 3 years prior to the first dose of investigational product.
- Prior or current treatment with the similar drug or related treatment specified in the protocol.
- Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
- Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
- Major arterial or venous thrombotic events within 3 months prior to first dose.
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 |
|---|---|---|
| ICP-B794Intravenous administration once every 3 weeks | Drug | ICP-B794 |
Primary outcome
Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0
Time frame: Up to 2 years
Dose-limiting toxicities (DLT)
Time frame: Up to 2 years
Incidence, character, and severity of dose-limiting toxicities.
The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD)
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: Up to 2 years
14 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Up to 2 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to 2 years
Half-life (T1/2)
Time frame: Up to 2 years
Area under the concentration-time curve from zero time to infinity (AUC0-∞)
Time frame: Up to 2 years
Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)
Time frame: Up to 2 years
Apparent Clearance (CL/F)
Time frame: Up to 2 years
Terminal Apparent Volume of Distribution (Vz/F)
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Radiographic progression-free survival (rPFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Number of participants with anti-drug antibodies (ADA) to ICP-B794
Time frame: Up to 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 22 Aug 2025.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Yilong Wu principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICP-B794 in people with Advanced Solid Tumors, run by Beijing InnoCare Pharma Tech 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 12 inclusion and 13 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: opening soon, as of the sponsor's last update on 22 Aug 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 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.
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 Yilong Wu (13809775415, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0 (time frame: Up to 2 years). The study lists 4 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 22 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.