A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

NCT05028478 | Unknown Phase 1 DMC

• 1 other identifier: CN202-102
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies

Conditions

Locally Advanced Solid Tumor; Metastatic Solid Tumor; Hematologic Malignancies

Outcome Measures

Primary Outcomes (4)

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through adverse events as assessed by NCI-CTCAE v5.0

  Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0

  Measurements at Baseline till 90 days after the last dose of study drug

• To evaluate the dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of CN202 when administered as a single-agent to subjects

  Measured by Incidence of dose limiting toxicities (DLT) during the first cycle of treatment and DLT observation period

  DLT assessed within 21 days after the first dose of CN202

• To identify a recommended Phase II dose (RP2D) of CN202

  The recommended Phase II dose (RP2D) will be determined based on safety, efficacy, pharmacokinetics and pharmacodynamic date of CN202

  Baseline to End of the Treatment assessed up to an average of 24 months

• To evaluate the anti-tumor activity of CN202 in selected solid tumors or hematologic malignancies as determined by Objective Response Rate (ORR)

  Measured/determined by Objective Response Rate

  Baseline to End of the Treatment assessed up to an average of 24 months

Secondary Outcomes (10)

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through Electrocardiogram (ECG)

  Baseline to End of the Treatment assessed up to an average of 24 months

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by heart rate

  Baseline to End of the Treatment assessed up to an average of 24 months

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by body temperature

  Baseline to End of the Treatment assessed up to an average of 24 months

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by pulse, systolic blood pressure, and diastolic blood pressure

  Baseline to End of the Treatment assessed up to an average of 24 months

• To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by respiratory rate

  Baseline to End of the Treatment assessed up to an average of 24 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Four planned CN202 dose level of 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg Subjects will receive CN202 by intravenous infusion (IV) on Day 1 of each cycle (once every 2 weeks) for up to 24 months

Drug: CN202

Interventions

CN202 DRUG

Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg

Single Arm

Eligibility Criteria

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

You may qualify if:

• Subjects ≥ age of 18 on the day of signing informed consent;
• Histologically or cytologically diagnosed metastatic or locally advanced solid tumor or hematologic malignancy (unresectable), for whom no effective standard anti-tumor therapy existed or in the opinion of the Investigator have been considered ineligible for standard anti-tumor therapy at this stage, or are intolerant to standard anti-tumor therapy, or standard therapy had failed or the subject has refused standard anti-tumor therapy, or recurrent and progressing since last line anti-tumor therapy;
• Representative tumor specimens in paraffin blocks (preferred) or at least 10 unstained slides, with an associated pathology report, requested at any time prior to study entry. Only tissue from core needle, punch, or excisional biopsy sample collection will be accepted. If archival tissue is insufficient or unavailable, the subjects may still be eligible upon discussion with Medical Monitor and approved by sponsor.
• At least 1evaluable tumor lesion per RECIST v1.1 (Solid Tumors) and Lugano 2014 Criteria (Lymphoma). Disease-specific criteria will be used for prostate cancer and or other tumors. The subjects enrolled in phase Ib/II study must have measurable disease.
• Subjects with Eastern Cooperative Oncology Group (ECOG) performance score of 0 to1;
• At least 3 months of expected survival;
• Female subjects must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception method from Screening until the end of the Safety Follow-up period, 90 (±7 days) days after the last dose of the study drug. Double contraception is defined as a condom AND one other from of the following:
• Established hormonal contraception (with approved OCPs, long-acting implantable hormones, injectable hormones);
• A vaginal ring or an intrauterine device (IUD);
• Documented evidence of surgical sterilization at least 6 months prior to screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men \[with appropriate post-vasectomy documentation of the absence of sperm in semen\] provided the male partner is a sole partner).
• Women not of childbearing potential must be post-menopausal for ≥12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
• Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.
• Female participants who are in same-sex relationships are not required to use contraception.
• Male subjects willing to use a highly effective method of contraception throughout the study period and for 90 days after the last dose of study drug.
• Subjects must be able to understand and sign the paper informed consent before any study specific procedure.

You may not qualify if:

• Received anti-tumor therapy, including radiotherapy, chemotherapy, hormonal therapy, immunotherapy, within 3 weeks prior to initiation of study treatment, however, the following are allowed:
• Palliative radiation therapy \> 2 weeks.
• Small molecule targeted therapy \> 2 weeks. But subject who has had anti-EGFR or anti-TKI (egerlotinib, gefitinib, afatinib, or crizotinib) \> 1 week prior to the first dose of study therapy.
• Use of immunomodulatory drugs \> 14 days or 5 half-lives of the drug prior to the first dose of study drug (whichever is shorter), including but not limited to thymosin, interleukin-2 (IL-2), interferon (IFN), etc.
• Herbal therapy \> 1 week.
• Hormone-replacement therapy or oral contraceptives.
• Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer.
• The subjects had prior treatment with anti-PD-L1 or anti-PD-1 therapeutic antibody, with the following exceptions:
• The subjects can be enrolled in Phase Ia study if no history of severe immune-related adverse effects from checkpoint inhibitor treatment or any that has led to discontinuation (CTCAE Grade 3 and 4).
• The subjects may be enrolled in Phase Ib/II study if the following requirements are met:
• \> 6 weeks from the last dose of anti-PD-L1 or anti-PD-1 therapeutic antibody
• No history of severe immune-related adverse effects from checkpoint inhibitor treatment or any that has led to discontinuation (CTCAE Grade 3 and 4).
• at least 3 months on PD1 with evidence of benefit or stable disease as per investigator' judgment.
• Subjects who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:
• \> 6 weeks from the last dose of anti-CTLA-4

Sponsors & Collaborators

• Curon Biopharmaceutical (Australia) Co Pty Ltd: lead
• Novotech (Australia) Pty Limited: collaborator

MeSH Terms

Conditions

Neoplasm Metastasis; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gary Richardson

  Cabrini Oncology Research

  PRINCIPAL INVESTIGATOR

• Morteza Aghmesheh

  Southern Medical Day Care Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Zhu

CONTACT

+86 138-1074-9637; danming.zhu@curonbiopharma.com

Fernanda Cecchin

CONTACT

+61 2 9171 3274; Fernanda.cecchin@novotech-cro.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: August 25, 2021
• First Posted: August 31, 2021
• Study Start: October 22, 2021
• Primary Completion: February 10, 2023
• Study Completion: October 6, 2023
• Last Updated: August 31, 2021

Record last verified: 2021-08