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Locally Advanced or Metastatic Solid TumorPhase 1NCT05194982

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

A Phase 1 study testing BL-B01D1 in people with Locally Advanced or Metastatic Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
BL-B01D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
8 sitesChina
Study dates
29 Nov 2021to Dec 2027
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

  • Participants must sign the informed consent form voluntarily and follow the plan requirements.
  • No gender limit.
  • Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
  • Expected survival time ≥ 3 months.
  • Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment.
  • Agrees to provide archived tumor tissue specimens or fresh tissue samples from the primary lesion or metastasis within 2 years; If a subject is unable to provide a tumor tissue sample, he/she may be enrolled after being evaluated by the investigator if other inclusion criteria are met.
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  • Participants must have at least one measurable lesion that meets the definition of RECIST v1.1.
  • Physical fitness score ECOG 0 or 1 point
  • Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss and grade 2 peripheral neurotoxicity, were excluded. Or decreased hemoglobin except ≥90 g/L).
  • No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%
  • The organ function level must meet the following requirements: a) bone marrow function: absolute neutrophilic granulocyte count (ANC) ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90 g/L; b) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; c) Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
  • Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT)≤1.5ULN.
  • Urinary protein ≤2+ or ≤1000mg/24h.
  • For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating; all participants (regardless of male or female) in the group should be treated throughout the treatment. Adequate barrier contraceptive measures should be taken during the treatment and 6 months after the treatment.

Who cannot join

  • Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2weeks prior to the first administration.
  • Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc.
  • Participants with prolonged QT interval (male QTc> 450 msec or female QTc> 470 msec), complete left bundle branch block, III grade atrioventricular block.
  • Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type I diabetes, hypothyroidism that can be controlled only by alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
  • Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection.
  • Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure>150 mmHg or diastolic blood pressure>100 mmHg).
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  • Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD).
  • Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set is excluded.
  • Symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases can be enrolled. Stable was defined as: a. The seizure-free state lasted for > 12 weeks with or without the use of antiepileptic drugs; b. Glucocorticoid use is not required; c. Consecutive MRI scans (at least 8 weeks between scans) showed stable imaging status.
  • Patients with a history of allergy to recombinant humanized antibody or mouse chimeric antibody or to any excipients of BL-B01D1.
  • Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
  • In previous adjuvant therapy with anthracyclines, the cumulative dose of anthracyclines was > 360 mg/m2.
  • Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 103 IU/ml) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower limit of detection).
  • Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, septicemia, etc.
  • Participated in another clinical trial (calculated from the time of the last dose) within 4 weeks prior to the first dose.
  • The other conditions of participation in this clinical trial were not considered appropriate by the investigators.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+86-15013238943

xiaosa@baili-pharm.com

8 sites in 1 country

China8 sites, 8 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Yaqian Han

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Yongsheng Li

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Zhang, PHD

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Jun Yang

    Recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality

    Ye Guo

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Weihua Yang

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Zhenming Fu

    Recruiting

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Kunyu Yang

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.

In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.

Being tested
BL-B01D1
Keywords
Non-Small Cell Lung Cancer (NSCLC), Small cell lung cancer (SCLC), Nasopharyngeal cacinoma (NPC), Head and Neck Cancer (HNC)
Medical subject headings
Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Head and Neck Neoplasms

What participants receive

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

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion.

Study groups in NCT05194982
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: BL-B01D1

What is being measured

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

  1. Phase Ia: Dose limiting toxicity (DLT)

    DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

    Measured: Up to 21 days after the first dose

  2. Phase Ia: Maximum tolerated dose (MTD)

    MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

    Measured: Up to 21 days after the first dose

  3. Phase Ib: Recommended Phase II Dose (RP2D)

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1

    Measured: Up to 21 days after the first dose

Secondary outcomes (13)

  1. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1 .

    Measured: Up to approximately 24 months

  2. Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Measured: Up to 21 days after the first dose

  3. Tmax

    Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated

    Measured: Up to 21 days after the first dose

  4. T1/2

    Half-life (T1/2) of BL-B01D1 will be investigated.

    Measured: Up to 21 days after the first dose

  5. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Measured: Up to 21 days after the first dose

  6. CL (Clearance)

    CL in the serum of BL-B01D1 per unit of time will be investigated.

    Measured: Up to 21 days after the first dose

  7. Ctrough

    Ctough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

    Measured: Up to 21 days after the first dose

  8. ADA (anti-drug antibody)

    Incidence and titer of ADA of BL-B01D1 will be evaluated.

    Measured: Up to approximately 24 months

  9. Nab (neutralizing antibody)

    Incidence and titer of Nab of BL-B01D1 will be evaluated.

    Measured: Up to approximately 24 months

  10. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

  11. Disease Control Rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  12. Duration of Response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  13. Progression-free Survival (PFS)

    The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted18 Jan 2022
  2. Study start29 Nov 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194982
Sponsor's protocol ID
BL-B01D1-101
Status last verified
Aug 2026
First submitted
4 Jan 2022
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao Y, Zhao H, Wang Q, Yang K, Li Y, Fu Z, Yang W, He Z, Wang Y, Ma Y, Yang Y, Fang W, Xiao S, Zhu H, Zhu Y, Zhang L, Huang Y. Izalontamab Brengitecan (Iza-Bren), a First-in-Class EGFR-HER3 Bispecific Antibody-Drug Conjugate in Extensive-Stage Small Cell Lung Cancer: Results From a Phase Ib Study. J Clin Oncol. 2026 Jul 24:JCO2600243. doi: 10.1200/JCO-26-00243. Online ahead of print.

    PubMed 42497381

  • Hong SD, Wang YS, Zhao HY, Zhao YY, Wang QM, Ma YX, Li YS, Huang Y, Yang YP, Fu ZM, Chen LK, Zhou F, Yang J, Li XY, Hou X, Zhou NN, Sun LH, Zhang GF, Cui JW, Wu L, Chen G, Zhang YX, Wang HY, Lv DQ, Shi JH, Jiang B, Li C, Li XL, Tang KJ, Yu Y, Ji YH, He ZY, Zhu Y, Zhu H, Xiao S, Zhou CC, Zhang L, Fang WF. Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: pooled analysis of phase I and phase II trials. Ann Oncol. 2026 Jun;37(6):813-824. doi: 10.1016/j.annonc.2026.01.009. Epub 2026 Jan 27.

    PubMed 41611210

  • Ma Y, Huang Y, Zhao Y, Zhao S, Xue J, Yang Y, Fang W, Guo Y, Han Y, Yang K, Li Y, Yang J, Fu Z, Chen G, Chen L, Zhou N, Zhou T, Zhang Y, Zhou H, Liu Q, Zhu Y, Zhu H, Xiao S, Zhang L, Zhao H. BL-B01D1, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study. Lancet Oncol. 2024 Jul;25(7):901-911. doi: 10.1016/S1470-2045(24)00159-1. Epub 2024 May 29.

    PubMed 38823410

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-B01D1 in people with Locally Advanced or Metastatic Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 8 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 14 inclusion and 16 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 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 Sa Xiao, PHD (+86-15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Dose limiting toxicity (DLT) (time frame: Up to 21 days after the first dose). The study lists 3 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 NCT05194982, which also lists 3 linked publications.

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 27 Aug 2026.

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