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mCRPCEarly Phase 1NCT06866548

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

A Early Phase 1 study testing anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab) in people with mCRPC, run by Shanghai Changzheng Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
mCRPC
What is being tested?
anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
10 Mar 2025to Nov 2028
Phase
Early 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 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men over 18 years old and under 85 years old;
  • Diagnosed with prostate adenocarcinoma by prostate biopsy pathology report;
  • Patients with metastatic castration-resistant prostate adenocarcinoma (mCRPC);
  • evidence of metastatic bone lesions on imaging such as PSMA-PET-CT or bone metastasis imaging ECT;
  • Serum testosterone in the depot range (< 50 ng/dL or 1.75 nmol/L);
  • Patients need to be willing to undergo pre- and on-treatment biopsy;
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  • ECOG score ≤ 2;
  • Expected survival time of 6 months or more;
  • Substantially normal bone marrow, liver and kidney function:
  • white blood cell (WBC) > 3 x 10^9 cells/L
  • Absolute neutrophil count (ANC) > 1×10^9 cells/L
  • Hemoglobin >9.0 g/dL
  • Platelet count >100×10^9/L
  • Serum creatinine <1.5 × upper limit of normal (ULN)
  • Serum total bilirubin <1.5 × ULN
  • Serum glutamine aminotransferase <3 × ULN
  • Aspartate aminotransferase <3 × ULN
  • willingness to cooperate and complete study follow-up and related tests.
  • The subject or his/her representative voluntarily participates in the study and signs a written informed consent; and
  • The questionnaire can be completed in Chinese.
  • The patient has been informed of the trial;

Who cannot join

  • Histologically predominantly other types of prostate cancer, such as sarcomas, lymphomas, small cell tumors, and neuroendocrine tumors;
  • Active infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5 o F or 38.1 o C) within 1 week prior to enrollment;
  • have received systemic, ongoing immunosuppressive therapy within 14 days prior to receiving study treatment (except for adrenal replacement steroid doses not exceeding 10 mg prednisone equivalent per day in the absence of active autoimmune disease or short-term steroid therapy (<5 days) within 7 days prior to initiation of study treatment);
  • Subjects with severe cardiovascular disease;
  • New York Heart Association (NYHA) Stage III or IV congestive heart failure;
  • episode of myocardial infarction or coronary artery bypass grafting (CABG) ≤ 6 months prior to enrollment;
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  • clinically significant ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or not due to dehydration;
  • history of severe non-ischemic cardiomyopathy;
  • reduced left ventricular ejection fraction (LVEF <55%), abnormal septal thickness and atrial size associated with myocardial amyloidosis, as assessed by echocardiography or multigated circuit exploration (MUGA) scan;
  • Organ function is in the following abnormalities:
  • serum aspartate aminotransferase or alanine aminotransferase > 2.5*ULN; CK > *ULN; CK-MB > *ULN; TnT > 1.5*ULN;
  • Total bilirubin > 1.5*ULN;
  • partial thromboplastin time or activated partial thromboplastin time or international normalized ratio > 1.5*ULN in the absence of anticoagulant therapy;
  • Patients who have planned or may plan to undergo extracorporeal radiation therapy or surgery for prostate cancer during the study period;
  • Prior anti-IGF-1R monotherapy and any immune checkpoint inhibitor therapy;
  • Intolerance to anti-IGF-1R monotherapy drugs and immune checkpoint inhibitors;
  • uncontrolled major active infectious disease, cardiovascular disease, pulmonary disease, hematologic disease, or psychiatric disease;
  • In the opinion of the investigator, not suitable for participation in this clinical study;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

This trial is designed to evaluate the safety and efficacy of anti-IGF-1R mAb in combination with anti-PD-1 mAb in patients with mCRPC.

Read the detailed description

This trial is designed to primarily confirm the safety and tolerability of anti-IGF-1R mAb (Teprotumumab/IBI311) in combination with anti-PD-1 mAb (Tislelizumab) using the recommended dose level for patients with mCRPC patients. Additionally，this trial is aimed to evaluate the clinical efficacy of anti-IGF-1R mAb combined with anti-PD-1 mAb in the treatment of mCRPC patients and to investigate whether the combined treatment can enhance endocrine therapy sensitivity in mCRPC patients. As for exploratory objectives，the trial is designed to identify and validate predictive biomarkers associated with therapeutic efficacy and safety profiles of the combination regimen in mCRPC patients.

Conditions
mCRPC
Being tested
anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)
Keywords
Prostate Cancer, Metastasis, PD-1, IGF-1R
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis, Insulin-Like Growth Factor I, Resistance To

What participants receive

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

  • anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)Drug

    Drug: Teprotumumab/IBI311 Given by IV infusion Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks.

    Drug: Tislelizumab Given by IV infusion 200 mg every 3 weeks

Study groups in NCT06866548
Study groupRoleWhat they receive
Treatment with anti-IGF-1R mAb(Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)ExperimentalNot described
Receives: Drug: anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab)

What is being measured

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

  1. Safety and adverse event incidence rate

    Incidence rate of adverse events graded according to the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: Through primary completion of study which may take up to 6 months.

Secondary outcomes (11)

  1. 3-month PSA progression-free survival (PSA-PFS)

    Time from enrollment to PSA progression as defined by PCWG3 or patient death.

    Measured: 3 months after first infusion

  2. 6-month imaging progression-free survival (rPFS):

    Time from enrollment to imaging progression or death from any cause, to be evaluated in conjunction with the RECIST 1.1 criteria and the PCWG3 criteria.

    Measured: 6 months after first infusion

  3. 6-month PSA progression-free survival (PSA-PFS)

    Time from enrollment to PSA progression as defined by PCWG3 or patient death.

    Measured: 6 months after first infusion

  4. PSA Response Rate

    Percentage of PSA decline from baseline according to PCWG3 criteria

    Measured: Through primary completion of study which may take up to 6 months.

  5. Disease Control Rate

    Defined as the proportion of patients whose tumors shrunk or remained stable for a certain period of time after treatment, judged according to RECIST 1.1 and PCWG3 to include the proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD).

    Measured: Through primary completion of study which may take up to 6 months.

  6. Objective Response Rate

    Define the proportion of patients with disease CR or PR as determined by RECIST 1.1 and PCWG3 , after treatment;

    Measured: Through primary completion of study which may take up to 6 months.

  7. Overall Survival

    Defined as the time from randomization grouping to the last available assessment or death;

    Measured: Through primary completion of study which may take up to 6 months.

  8. Incidence of bone metastasis-related events (SREs)

    Incidence of bone radiotherapy (including radioisotopes), pathologic fractures (excluding trauma), spinal cord compression, and bone surgery.

    Measured: Through primary completion of study which may take up to 6 months.

  9. Quality of life (QoL)

    QoL was monitored using the validated and self-rated EORTCQLQ-C30

    Measured: Through primary completion of study which may take up to 6 months.

  10. Quality of life (QoL) FACT-P questionnaire

    QoL was monitored using the validated and self-rated questionnaire

    Measured: Through primary completion of study which may take up to 6 months.

  11. Time to pain progression

    Time from the date of randomization to the date on which the pain severity score (using the BPI-SF) increased by 30% or more from baseline. Or the time from the date of randomization to the date of observation of a 2-point increase from baseline in the BPI-SF worst pain intensity (point 3 on the scale) on 2 consecutive assessments ≥4 weeks apart or initiation of chronic opioid use, whichever occurred first.

    Measured: Through primary completion of study which may take up to 6 months.

Timeline

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

  1. First posted10 Mar 2025
  2. Study start10 Mar 2025
  3. Primary completion11 Nov 2025
  4. Study completionNov 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866548
Sponsor's protocol ID
HELIX-25
Status last verified
Jul 2026
First submitted
3 Mar 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the consent and approval of principal investigator, but this does not mean all requests will be approved.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-IGF-1R mAb (Teprotumumab/IBI311) + anti-PD-1 mAb (Tislelizumab) in people with mCRPC, run by Shanghai Changzheng 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 21 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse event incidence rate (time frame: Through primary completion of study which may take up to 6 months.). 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 NCT06866548.

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 23 Jul 2026.

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