Health TrialsbyHealthPanel

CW-301 FIH Study of CAN016

ConditionPatients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanwell Biotech Limited

About this trial

A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide informed consent voluntarily

Male or female patients ≥18 years of age.

Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.

For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;

Disqualifiers

Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.

Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.

Patients have autologous transplantation within 3 months.

Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CAN016

    Drug

    CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.

  • CAN016

    Drug

    an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1. A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed. Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met

Treatment groups

90 Participants
are divided into 4 treatment groups
Group A: patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancerExperimental treatment 1 intervention
Group B: HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancerExperimental treatment 1 intervention
Group C: HER2 expression or mutation advanced solid tumorsExperimental treatment 1 intervention
Group D: For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicities (DLT)

Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 21 days) of each investigated dose levels.

Time frame
12 months
2

Tumor objective response rate (ORR)

Tumor objective response rate (ORR) defined as the sum of complete response (CR) rate and partial response (PR) rate as best reported by Response Evaluation Criteria in Solid Tumors (RECIST1.1)

Time frame
36 months

Secondary outcomes

1

Safety and Tolerability

AE type, incidence, duration, severity and seriousness of AEs, physical examination, laboratory data, vital signs and ECG changes according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0.

Time frame
48 months
2

Pharmacokinetic measures - concentration time Area Under the Curves

Measure the variation of CAN016 concentration in blood as a function time

Time frame
12 months
3

Pharmacokinetic measures - Cmax

Measure the maximum (peak) blood concentration(s) of CAN016

Time frame
12 months
4

Pharmacokinetic measures - Tmax

Measure of time to reach maximum (peak) blood concentration(s) following administration of CAN016

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canwell Biotech Limited

Lead sponsor

Source ClinicalTrials.gov
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