A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Official title

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Overview

This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.

Interventions

• Drug BL-M07D1
  Administration by intravenous infusion

Primary outcome measures

• Phase Ib: Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]
• Phase II: Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]

Secondary outcome measures (9)

• Treatment-Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]
• Phase Ib: Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
• Duration of Response (DOR) [Time frame: Up to approximately 24 months]
• Progression-free Survival (PFS) [Time frame: Up to approximately 24 months]
• Cmax [Time frame: Up to approximately 24 months]
• Tmax [Time frame: Up to approximately 24 months]
• Ctrough [Time frame: Up to approximately 24 months]
• ADA (anti-drug antibody) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Female;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;
• The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;
• Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• No blood transfusion, use of any cell growth factors and/or platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;
• Urinary protein ≤2+ or ≤1000mg/24h;
• albumin ≥30 g/L;
• Women who are likely to give birth must have negative serum/urine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment cycle and for 6 months after the end of treatment.

Exclusion criteria

• had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;
• had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
• had a history of serious cardiovascular and cerebrovascular diseases;
• active autoimmune or inflammatory diseases;
• Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate/cervix/breast cancer in situ;
• Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;
• patients with massive or symptomatic effusions or poorly controlled effusions;
• Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
• patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases);
• patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;
• patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;
• had participated in another clinical trial within 4 weeks before the first dose;
• pregnant or lactating women;
• The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06131450 · BL-M07D1-203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗