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RecruitingNCT05909241Updated Apr 25, 2024

A Study of BA1202 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of BA1202 in Advanced Solid Tumor, sponsored by Shandong Boan Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Shandong Boan Biotechnology Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B).

Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.

02

Conditions studied

  • Advanced Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 78 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shandong Boan Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.
  • Part A: Patients with histologically and/or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.
  • Part B: Patients with histologically and/or cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.(Specific cohort will be determined after data of dose escalation phase is obtained)
  • Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and/or 3+).
  • Life expectancy of at least 3 months.
  • At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1.
  • ECOG score of \< 2.
  • Absolute neutrophil count ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, hemoglobin ≥ 90 g/L.
  • Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).
  • Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL/min.
  • International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
  • Blood pregnancy test results were negative for female patients with fertility potential. Patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration.

Exclusion criteria

Exclusion Criteria:

  • Other malignancies within 5 years prior to screening (other than cured stage Ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer).
  • Has a persistent or active infection that requires intravenous treatment.
  • History of severe cardiovascular and cerebrovascular disease.
  • Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.
  • Received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of BA1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives.
  • Have received any previous CEA targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (ADCs), chimeric antigen receptor T cells (CAR-T), etc.
  • A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.
  • Women are planning to become pregnant or are pregnant or breastfeeding.
  • Other conditions considered unsuitable for enrollment by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    BA1202

    BA1202 is a bispecific antibody targeting CEA and CD3.

    Drug: BA1202

Interventions

  • DrugBA1202

    BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B.

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: 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

  1. Maximum Concentration (Cmax) of BA1202

    Time frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)

  2. Area under the curve (AUC) of BA1202

    Time frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)

  3. Minimum Concentration (Cmin) of BA1202

    Time frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)

  4. Time of maximum concentration (Tmax) of BA1202

    Time frame: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)

  5. Objective Response Rate (ORR)

    Time frame: up to 2 years

  6. Disease Control Rate (DCR)

    Time frame: up to 2 years

  7. Duration of Response (DOR)

    Time frame: up to 2 years

  8. Overall Survival (OS)

    Time frame: up to 2 years

  9. Progression-Free Survival (PFS)

    Time frame: up to 2 years

  10. Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab)

    Time frame: Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)

07

Study locations

1 of 1 sites recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences
    Beijing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05909241
Lead sponsor
Shandong Boan Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Aug 16, 2023
Primary completion
Feb 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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