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Solid TumorPhase 1/2NCT05869240

BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors

A Phase 1/2 study testing BPB-101 in people with Solid Tumor, run by Betta Pharmaceuticals Co., Ltd. at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of BPB-101. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
BPB-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
4 sitesChina
Study dates
16 May 2023to 1 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Subjects voluntarily participate in the trial and sign an informed consent form.
  • Male or female subjects aged between 18 and 75 years.
  • Subjects with cytologically or histologically confirmed advanced solid tumor for which no standard therapy is available or standard therapy has failed in dose-escalation phase; In the dose-expansion phase, subjects enrollment included, but not limited to, with non-small-cell lung, esophageal, colorectal, endometrial, melanoma, bladder, and breast cancers (actual enrollment could be determined based on available data).
  • Life expectancy >= 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Participants enrolled in the dose-escalation phase (phase Ia) must have evaluable disease per RECIST 1.1. Participants enrolled in the dose expansion and clinical expansion phase (phase Ib and II) must have at least one measurable disease per RECIST 1.1.
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  • Adequate hematologic and organ function at screening, as follows:
  • Absolute neutrophil count (ANC)≥1.5×10^9/L, Platelets≥100×10^9/L, Hemoglobin≥9g/dL(90g/L)
  • Serum total bilirubin ≤1.5×upper limit of normal (ULN), unless liver cancer or liver metastases are present, then values must be ≤2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, unless liver cancer or liver metastases are present, then values must be ≤5×ULN
  • Serum creatinine≤1.5×ULN OR creatinine clearance (CrCl)≥50ml/min (using the Cockcroft-Gault formula)
  • International normalized ratio (INR) and prothrombin time ≤1.5×ULN; And activated partial thromboplastin time (aPTT) ≤1.5×ULN.
  • Female subjects with childbearing potential must have a negative serum pregnancy test at screening (within 7 days of first dose of study drug). Female subjects with childbearing potential and male subjects with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the screening visit through 6 months after the last dose of study drug is received.

Who cannot join

  • Known hypersensitivity to any component and excipients of the investigational drug, or previous severe allergic reaction to any macromolecular monoclonal antibody.
  • Received anti-PD-1 or PD-L1 antibodies within 3 months prior to screening. Previously received treatment targeting TGF-β, TGF-β receptors, or GARP.
  • Received other antitumor therapies, such as chemotherapy, biological therapy, endocrine therapy, etc., within 4 weeks before the first dose. Local palliative treatment (such as local surgery or radiotherapy) for isolated lesions can be received without affecting the efficacy evaluation. Enrollment is permitted in the following cases:
  • Oral pyrimidine or small molecule targeted therapy drugs are used more than 2 weeks or 5 half-lives of the drug (whichever is longer) before the first dose.
  • Nitrosourea or mitomycin C are used more than 6 weeks before the first dose.
  • Major surgery within 4 weeks before first dose of study drug.
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  • Systemic therapy with immunosuppressive agents within 2 weeks prior to the first dose of study drug or during the study, except for corticosteroid nasal sprays, inhalers, or ≤10 mg/day systemic prednisone and equivalent medications.
  • Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 5 years.Except for malignancies that can be expected to heal after treatment (including but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or carcinoma in situ of the breast duct treated with radical surgery).
  • Presence of symptomatic central nervous system metastases, meningeal metastases, or spinal cord compression due to metastases. Except for patients with brain metastases who have symptoms before the first dose, but whose disease is stable for ≥ 4 weeks after treatment.
  • Subjects with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer; Those with a history of melena and hematemesis within 2 months before administration; Researchers believe that visceral bleeding may occur.
  • Patients with large and uncontrolled pleural effusions, pericardial effusions, or abdominal effusions requiring repeated drainage.
  • Has an active autoimmune disease requiring systemic treatment within 2 years prior to initial medication.
  • Cardiovascular diseases of clinical significance, including:
  • Clinically uncontrolled hypertension;
  • The following conditions occurred within 6 months before the first medication:
  • Congestive heart failure (New York Heart Association Grade III or IV);
  • Arrhythmias or conduction abnormalities that require medical treatment. Note: Subjects with drug-controlled atrial fibrillation/atrial flutter and pacemaker controlled arrhythmia can be enrolled;
  • Severe/unstable angina, coronary/peripheral bypass graft, or myocardial infarction; (Note: Severe angina is Grade III or IV of the Canadian Cardiovascular Society)
  • Cerebrovascular accident or transient ischemic attack, transient myocardial ischemia;
  • Any other arterial thrombosis or embolic event.
  • Severe active infection within 2 weeks prior to initial administration, or systemic anti-infection therapy lasting more than 7 days after intravenous use within 1 week prior to initial administration.
  • Toxicity due to previous antitumor therapy has not returned to CTCAE 5.0 level ≤1 (except for toxicity such as alopecia where the investigator determined no safety-related risk).
  • There is active tuberculosis, or interstitial lung disease requiring treatment.
  • History of bone marrow allotransplantation or solid organ transplantation.
  • HIV-positive or active syphilis infection.
  • Have active hepatitis B and C.
  • Pregnant or lactating women.
  • Have received live or attenuated vaccine within 180 days prior to initial administration of study drug (Note: Inactivated virus vaccine is allowed. Seasonal flu vaccines that do not contain live viruses are allowed. Inactivated COVID-19 vaccine is allowed, but needs to be eluted for 1 week before first administration).
  • Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance or the subject's signing of informed consent, or may be inappropriate for participation in the clinical trial.
  • Inability or unwillingness to follow the research and/or follow-up procedures outlined in the programme.

Trial locations and contacts

4 sites in 1 country.

Weizhi Gu contact

0086-0571-85856809

weizhi.gu@bettapharma.com

China4 sites, 4 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Keqiang Zhang, 0086-13054196067, zhangkeqiang@hnca.org.cn

    Not yet recruiting

  • Sichuan Academy of Medical Sciences-Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Haitao Lan, 0086-18981838376, lanht@sina.com

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

    Li Zhang, 0086-13902282893, zhangli@sysucc.org.cn

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Suxia Luo, 0086-18638553211, luosxrm@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I/II, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPB-101 in Patients With Advanced Malignant Solid Tumors.

This is a multi-center, open-label, Phase I/II clinical study of BPB-101 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of BPB-101.

Read the detailed description

This trial consist of 3 parts: dose escalation(phase Ia), dose expansion(phase Ib) and clinical expansion(phase II) part. The current trial is composed of dose escalation with accelerated titration and "3 + 3" cohort design (phase Ia), for which 1 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLT), followed by a consecutive parallel-group expansion in selected dose levels (phase Ib) and selected solid tumor indications (phase II). Participants enrolled in Phase 2 will receive the Recommend Phase 2 Dose (RP2D) of BPB-101 (determined by phase Ia dose escalation and phase Ib dose expansion) until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

Conditions
Solid Tumor
Being tested
BPB-101
Keywords
BPB101, solid tumor

What participants receive

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

  • BPB-101Drug

    Subjects will receive an intravenous infusion of BPB-101 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.

Study groups in NCT05869240
Study groupRoleWhat they receive
BPB-101ExperimentalNot described
Receives: Drug: BPB-101

What is being measured

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

  1. DLT of BPB-101

    DLT is defined as a dose-limiting toxicity event occurring during the DLT observation period that, as determined by the Investigator and/or Sponsor to be at least possibly related to BPB-101, is classified using NCI-CTCAE version 5.0 as conforming to adverse events (AEs) or laboratory anomalies specified in the protocol.

    Measured: Up to 21 days after first treatment in Phase Ia

  2. Maximum Tolerated Dose (MTD) of BPB-101

    MTD was defined as the maximum dose of <1/3 DLT events observed in patients with evaluable DLT events (i.e., 1 in 6 patients at most).

    Measured: Up to 21 days after first treatment in Phase Ia

  3. RP2D of BPB-101

    RP2D is determined based on safety, tolerability, pharmacokinetics and efficacy data.

    Measured: Throughout Phase Ia and Ib，approximately 2 years

  4. Number of subjects with adverse events (AEs)

    An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.

    Measured: Up to 30 days after last treatment

Secondary outcomes (11)

  1. Dose Escalation and Expansion Part: Maximum concentration (Cmax)

    Serum BPB-101 concentrations measured throughout the study.

    Measured: Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

  2. Dose Escalation and Expansion Part: Minimum concentration (Cmin)

    Serum BPB-101 concentrations measured throughout the study.

    Measured: Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

  3. Dose Escalation and Expansion Part: Area under the concentration-time curve from zero to last sampling time (AUC0-t)

    Serum BPB-101 concentrations measured throughout the study.

    Measured: Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

  4. Dose Escalation and Expansion Part: Half-life (T1/2)

    Serum BPB-101 concentrations measured throughout the study.

    Measured: Predose ,0, 2, 6, 24, 48, 168 and 336 hours post dose at cycle 1 and 3 (each cycle is 21 days); predose at cycle 2, 4 and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

  5. Immunogenicity of BPB-101

    Serum concentrations of anti-BPB 101 antibody measured throughout the study.

    Measured: Predose of cycle 1, 2, 3, 4 (each cycle is 21 days), and every 4 cycles after cycle 8 until progression or end of the treatment whichever occur first, assessed up to 2 years.

  6. Objective Response Rate (ORR)

    Defined as the percentage of participants in the analysis population who had a Complete Response (CR) or Partial Response (PR) per iRECIST and RECIST 1.1(Phase 2 only).

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 2 years

  7. Duration of Response (DOR)

    Defined as time from first observation of response to first observation of documented disease progression (or death) per iRECIST and RECIST 1.1(Phase 2 only)

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 2 years

  8. Disease Control Rate (DCR)

    Defined as proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD) per iRECIST and RECIST 1.1(Phase 2 only)

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 2 years

  9. Time to Response (TTR)

    Defined as the time from the first dose date to first observation of response per iRECIST and RECIST 1.1(Phase 2 only).

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 2 years

  10. Progression-free Survival (PFS)

    Defined as time from first treatment administration to first observation of documented disease progression (or death）, per iRECIST and RECIST 1.1(Phase 2 only).

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 2 years

  11. Overall survival (OS)

    Defined as time from start of treatment to death.

    Measured: Evaluated throughout the protocol, for the duration of the trial, up to approximately 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 posted22 May 2023
  2. Study start16 May 2023
  3. Primary completion2 Aug 2025 (estimated)
  4. Study completion1 Sep 2025 (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
Single group
Masking
None (open label)
Enrolment
388 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05869240
Sponsor's protocol ID
BTP-61811
Status last verified
Jun 2023
First submitted
23 Apr 2023
Last updated
6 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ma Y, Guo Y, Deng S, Lan H, Luo S, Zhang K, Hu Q, Fu T, Wu P, Cao Q, Zhao L, Mao L, Ding L, Huang Y, Zhao Y, Zhang Y, Xue J, Zhang L, Zhao H. A phase Ia first-in-human study of BPB-101, a novel trifunctional antibody targeting the GARP/TGF-beta complex and PD-L1, in patients with locally advanced or metastatic solid tumors. J Hematol Oncol. 2026 Nov 3;19(1):99. doi: 10.1186/s13045-026-01867-7.

    PubMed 42978019

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BPB-101 in people with Solid Tumor, run by Betta Pharmaceuticals Co., Ltd. at 4 sites 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 30 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weizhi Gu (0086-0571-85856809, weizhi.gu@bettapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT of BPB-101 (time frame: Up to 21 days after first treatment in Phase Ia). 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?

On the ClinicalTrials.gov record for NCT05869240, which also lists 1 linked publication.

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 6 Jun 2023.

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