Testing BB-1705 in patients with advanced solid tumors

A Phase I First-in-human, Open Label, Multicenter, Dose Escalation and Cohort Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1705 in Patients With Locally Advanced/Metastatic Solid Tumors

This study is testing a new treatment called BB-1705 to see if it is safe and can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years to 78 Years
• Sex: All
• Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 7 sites (Beijing and 6 other locations)
• Trial ID: NCT05217693 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the safety and tolerability of BB-1705 in patients with locally advanced or metastatic solid tumors. It consists of two phases: a dose-escalation phase to determine the maximum tolerated dose (MTD) and a cohort expansion phase to further assess safety, pharmacokinetics, and preliminary anti-tumor activity at the recommended phase 2 dose (RP2D). Eligible participants must have progressed on prior standard therapies and have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed locally advanced or metastatic solid tumors that are unresectable.

Not a fit: Patients with early-stage tumors that are resectable or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies involving antibody-drug conjugates (ADCs) have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent form (ICF) for the trial.
2. Adult patients ≥ 18 years at the time of signing ICF.
3. Patient must have a histologically or cytologically confirmed, locally advanced, unresectable, or metastatic solid tumors:
4. At least one measurable lesion as defined per RECIST Version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy ≥12 weeks.
7. Adequate organ function as indicated by the following laboratory values (had not received blood transfusion, EPO, G-CSF, or other medical support within the 14 days before the administration of BB-1705):
8. Women of childbearing potential and males with fertile female partner must be willing to use currently accepted reliable contraception method throughout the treatment period from ICF signed and for at least 6 months following the last dose of BB-1705. These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of IUS intrauterine device); or use of barrier methods such as condoms or septum and spermicide products. Postmenopausal women over 50 years of age must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of investigational product.

Exclusion Criteria:

1. Receiving cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment
2. Prior history of other malignancies.
3. Not recovered to baseline or ≤ grade 1 adverse events from prior anti-cancer treatment.
4. Major surgery within 4 weeks and minor surgery within 2 weeks before the first dose or not fully recovered from surgery; or surgery planned during the time the patient is expected to participate in the study
5. Grade 2 or higher peripheral neuropathy.
6. Active pneumonitis/interstitial lung disease (ILD), a history of pneumonitis/ILD that required systemic steroids, received radiotherapy to lung field within 12 months before the first dose of study intervention, or current clinically relevant-lung disease
7. Symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases, including steroids (\>10 mg of prednisone or 4 mg of dexamethasone) and antiepileptic agents.
8. Any other serious ongoing underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection, vaccination within 4 weeks, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents within 6 months of study entry, gastrointestinal bleeding within 3 months of study entry, severe signs and symptoms of coagulation and clotting disorders.
9. QTc interval ≥450 ms for male or ≥470 ms for female (Fridericia's formula) and patients with congenital long QT syndrome.

Where this trial is running

Beijing and 6 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• Hunan Cancer Hospital — Changsha, China (Recruiting)
• First affiliated hospital of Gannan medical university — Ganzhou, China (Recruiting)
• Bliss Biopharmaceutical Co, Ltd — Hangzhou, China (Recruiting)
• Zhejiang University School of Medicine - The First Affiliated Hospital — Hanzhou, China (Recruiting)
• Linyi Cancer Hospital — Linyi, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Recruiting)

Conditions Solid Tumor; ADC