A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Positive Solid Tumors

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 positive solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd

Criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent for the trial.

2. Male or female subject ≥ 18 years.

3. Subjects must have a histologically or cytologically confirmed locally advanced unresectable or metastatic HER2 positive solid tumor(s) for which no curative therapy is available or tolerable.

4. Subjects must have at least one measurable lesion as defined per RECIST Version 1.1.

5. Eastern Cooperative Oncology Group performance status of 0 or 1.

6. Life expectancy ≥12 weeks.

7. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.0 × ULN OR ≤ 3.0 × ULN for subjects with liver metastases.

8. Subjects (women of childbearing potential and males with fertile female partner) must be willing to use currently accepted reliable contraception method throughout the treatment period and for at least seven months following the last dose of study drug.

Exclusion Criteria:

1. Subjects receiving cancer therapy at the time of enrollment.

2. Has not recovered from adverse events due to a previously administered agent.

3. Had major surgery within 4 weeks before dosing.

4. Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.

5. Subjects who have received prior cumulative doxorubicin dose > 360 mg/m² or equivalent

6. Subjects with > Grade 2 peripheral neuropathy

7. Has an 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

8. Subjects with symptomatic or untreated central nervous system metastases, or those requiring ongoing treatment for central nervous system metastases, including steroids and antiepileptic agents.

9. Any other serious underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders.

10. Subjects with clinically significant cardiovascular disease, current dyspnea at rest due to complications of advanced malignancy.

11. Active viral hepatitis (B or C)

12. History of life-threatening hypersensitivity, or known to be allergic to protein drugs or recombinant proteins

13. Any other serious underlying medical conditions, including but not limited to, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications

14. Females who are pregnant