A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors

NCT05650242 | Recruiting Phase 1

• 1 other identifier: BA1106/CT-CHN-101
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.

Conditions

Solid Tumors

Keywords

BA1106; First in human study; safety

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).

  From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.

Secondary Outcomes (14)

• Area under the curve (AUC) of BA1106

  up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)

• Half-life (t1/2) of BA1106

  up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)

• Maximum Concentration (Cmax) of BA1106

  up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)

• Minimum Concentration (Cmin) of BA1106

  up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)

• Time of maximum concentration (Tmax) of BA1106

  up to cycle 6nd (cycle 1st is 28 days, the other cycles are 21 days)

Study Arms (1)

BA1106

EXPERIMENTAL

Part A (Dose-Escalation): Mixed solid tumors participants will receive ascending doses of BA1106. BA1106 will be administered by intravenous (IV) infusion. The observation period of Dose Limiting toxicity (DLT) is 28 days, then the participants will receive BA1106 every three weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years. Part B (Dose-Expansion): Participants of selected tumors will receive a fixed dose of BA1106 that selected according to the results of Part A once every 3 weeks (Q3W) or once every 2 weeks (Q2W), until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the maximum duration of administration was no more than 2 years.

Drug: BA1106

Interventions

BA1106 DRUG

In part A, after the observation period of DLT (28 days), intravenous (IV) once every 3 weeks (Q3W). In Part B, intravenous (IV) once every 3 weeks (Q3W) or once every 2 weeks (Q2W).

BA1106

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent and to comply with the study protocol;
• Subject with histologically or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on all standard therapies, are intolerant to Standard-Of-Care (SOC), and/or are non-amenable to SOC;
• At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1;
• Able to provide the most recent archival tumor tissue samples (negotiable);
• Life expectancy \>=12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Adequate major organ function;
• Women of Childbearing Potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods;
• Men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods and refrain from donating sperm.

You may not qualify if:

• Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention;
• Participants with any infection requiring intravenous therapy, or any other uncontrolled active infection, within 2 weeks prior to informed consent;
• Participants with symptomatic radiation pneumonia, radiation esophagitis, radiation colitis; extensive interstitial lung disease of both lungs, chronic obstructive pulmonary disease requiring bronchodilators or regular hormonal therapy; unhealed peptic ulcers, cirrhosis and related complications, chronic enteritis, necrotizing enteritis, gastrointestinal obstruction (except those who are relieved with treatment and have no safety risk as assessed by the investigator), gastrointestinal bleeding tendency or high risk of perforation, pancreatitis requiring treatment; arteriovenous thrombotic disease; chronic nephritis and nephrotic syndrome, within 8 weeks prior to C1D1;
• Participants with active autoimmune disease or the risk of recurrence;
• Participants with major cardiocerebral vascular disease;
• Participants with body cavity effusion requiring local treatment or determined as poorly controlled by the investigator;
• History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or DIHS (drug-induced hypersensitivity syndrome);
• Participants with diseases affecting intravenous injection and venous blood collection;
• Prior use of any anti-cancer therapy (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, traditional Chinese medicine, etc.) within 4 weeks, or non-antitumor traditional Chinese medicine within 2 weeks, prior to C1D1;
• Prior use of drugs targeting IL-2 receptors;
• History of being receipt of any organ transplantation or allogeneic stem-cell transplantation;
• Risk of gastrointestinal ulcers or bleeding as assessed by the investigator;
• Prior treatment with systemic immunosuppression excluding nasal/inhaled corticosteroids or physiological dosed systemic corticosteroids, within 2 weeks prior to C1D1;
• Prior treatment with cytokine, blood transfusion, or blood products within 4 weeks prior to C1D1;
• Participants with major surgical procedure or significant traumatic injury, within 4 weeks prior to C1D1; or with wound healing complications before enrolment;

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 10036, China

RECRUITING

Central Study Contacts

Lin Shen

CONTACT

13911219511; doctorshenlin@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 14, 2022
• Study Start: January 31, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)