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Advanced Solid TumorPhase 1/2NCT07901413

Evaluation of ICP-B381 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing ICP-B381 in people with Advanced Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B381 in the trial participants of advanced solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ICP-B381
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
348 participants
Where
1 siteChina
Study dates
Nov 2026to Jul 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be at least 18 years old.
  • Participants thoroughly understand study procedures, and voluntarily sign the written ICF
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
  • Expected survival time ≥3 months.
  • Histopathologically confirmed metastatic castration-resistant prostate cancer (mCRPC) \& Other advanced solid tumor
  • Agree to provide FFPE slides from archived tumor tissues collected within the past 2 years or fresh tumor biopsies (for archived samples, more recently collected specimens are preferred
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  • The organ function level must meet the prescribed standards
  • All toxicities derived from previous anti-neoplasm treatments must have been resolved to Grade ≤1 (per CTCAE V6.0)
  • Effective contraceptive measures should be taken from the date of signing the informed consent form until at least 6 months after the use of the last dose of the study drug
  • Female participant of childbearing potential must have a negative blood pregnancy test at the screening visit
  • Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose.
  • Participants can communicate well with the Investigator and can complete the study according to the study protocol

Who cannot join

  • Other active malignant tumors occurred within 3 years before the first administration of the study drug
  • Has previously received or is currently receiving the same type of drug or related treatment as stipulated in the protocol
  • Has a previous medical history and adverse life history as specified in the protocol, or has a disease as specified in the protocol
  • Has received cytotoxic chemotherapy, radical radiotherapy, molecular targeted therapy, immunotherapy, anti-tumor vaccine therapy, cytokine therapy, or other investigational anti-cancer drugs with an elution time not meeting the protocol requirements
  • Had active bleeding within 2 months before screening or had clinically significant or significant bleeding tendency, or was experiencing bleeding symptoms due to taking anticoagulant drugs or other medical interventions
  • Had major surgery within 28 days before the first administration or minor surgery within 2 weeks before the first administration
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  • Has received systemic immunosuppressive drugs as stipulated in the protocol for 14 days before the first administration
  • Has a history of severe allergic reactions to the active ingredient, non-active ingredients in the drug, or antibody-based drugs
  • Had the first administration within 2 weeks before or is planned to use drugs or foods with strong inhibitory or inducing effects on cytochrome P450 CYP3A before the study
  • Has any mental or cognitive disorders that may limit their understanding, execution of the informed consent form, and compliance with the study
  • Situations that the investigator deems unsuitable for participating 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.

Jingnan Yang contact

010-66609990

CO-Clinicaltrial@innocarepharma.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    DingWei Ye, M.D., 021-64175590*81807, dwyeli@163.com

Other trials in China

About this study

Official title: An Open, Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics, and Efficacy of ICP-B381 in Participants With Advanced Solid Tumors

To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B381 in the trial participants of advanced solid tumors

Being tested
ICP-B381

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-B381Drug

    ICP-B381 will be administered by intravenous infusion every 3 weeks (Q3W) until disease progression (PD) or the occurrence of unacceptable toxicity or withdrawal from the study for other reasons (whichever occurs first).

Study groups in NCT07901413
Study groupRoleWhat they receive
ICP-B381ExperimentalNot described
Receives: Drug: ICP-B381

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The type, severity (assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 [NCI-CTCAE V6.0]), relationship to the investigational product, and incidence rate of adverse event (AE) and serious advers

    Measured: 2 years

  2. The type, severity (assessed according to NCI-CTCAE V6.0), and incidence rate of dose limiting toxicity (DLT)

    Measured: 2 years

  3. Single-agent Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD)

    Measured: 2 years

  4. Participants with prostate cancer: Prostate-specific antigen (PSA50) response rate evaluated by Investigator according to Prostate Cancer Working Group 3 (PCWG3) criteria

    Measured: 2 years

  5. Participants with other tumor types: Investigator-assessed Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 criteria

    Measured: 2 years

  6. The optimal dosing regimen for the subsequent study of ICP-B381

    Measured: 2 years

Secondary outcomes (21)

  1. Maximum Concentration (Cmax)

    Measured: 2 years

  2. Time to Maximum Plasma Concentration (Tmax)

    Measured: 2 years

  3. Half-life (T1/2)

    Measured: 2 years

  4. Area Under the Serum or Plasma Concentration-Time Curve (AUC0-∞ and AUC0-t)

    Measured: 2 years

  5. Apparent Clearance Rate (CL/F)

    Measured: 2 years

  6. Terminal Apparent Volume of Distribution (Vz/F)

    Measured: 2 years

  7. Steady-state Pharmacokinetic Parameters

    Measured: 2 years

  8. ORR

    Measured: 2 years

  9. Disease Control Rate (DCR)

    Measured: 2 years

  10. Duration of Response (DOR)

    Measured: 2 years

  11. Participants with prostate cancer: radiographic progression-free survival (rPFS) evaluated by the Investigator according to RECIST V1.1 criteria (for soft tissue lesions) and PCWG3 criteria (for bone lesions)

    Measured: 2 years

  12. Participants with prostate cancer: changes in serum PSA levels compared to baseline during the study: PSA50 response rate

    Measured: 2 years

  13. Participants with prostate cancer: PSA90 response rate

    Measured: 2 years

  14. Participants with prostate cancer:12-week PSA response rate

    Measured: 2 years

  15. Participants with prostate cancer: time to PSA progression (TTPP)

    Measured: 2 years

  16. Time to First Subsequent Therapy (TFST)

    Measured: 2 years

  17. Overall Survival (OS)

    Measured: 2 years

  18. Participants with prostate cancer: incidence rate of symptomatic skeletal event (SSE)

    Measured: 2 years

  19. Participants with prostate cancer: time to first symptomatic skeletal event (TTSSE)

    Measured: 2 years

  20. Incidence rate of anti-drug antibody (ADA) against ICP-B381

    Measured: 2 years

  21. Types, severity (assessed according to NCI-CTCAE V6.0), relationship with the investigational product, and incidence rate of AE and SAE

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
348 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901413
Sponsor's protocol ID
ICP-CL-01901
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-B381 in people with Advanced Solid Tumor, 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 11 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 28 Oct 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 Jingnan Yang (010-66609990, CO-Clinicaltrial@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The type, severity (assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 [NCI-CTCAE V6.0]), relationship to the investigational product, and incidence rate of adverse event (AE) and serious advers (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07901413.

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 28 Oct 2026.

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