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Monoclonal Antibodies

CPO301 for Cancer

Phase 1

Recruiting

Research Sponsored by Conjupro Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1

In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head & neck cancer based on previous biopsy result

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial tests a new drug to see if it is safe and to assess its effectiveness in treating advanced solid tumors.

Who is the study for?

Adults with advanced or metastatic solid tumors, including lung cancer, who have progressed after prior treatments or can't tolerate them. Participants must be over 18, have a life expectancy of more than 12 weeks and at least one measurable tumor. Those with specific EGFR mutations in their lung cancer are also eligible.Check my eligibility

What is being tested?

CPO301 is being tested for safety and effectiveness in two parts: first to find the right dose (Part A) and then to test it on non-small cell lung cancer patients with EGFR mutations and other cancers (Part B). It's given by IV every three weeks.See study design

What are the potential side effects?

Possible side effects of CPO301 include reactions related to the immune system since it's an antibody drug conjugate. Specific side effects will be monitored but may involve typical chemotherapy-related issues like fatigue, nausea, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one tumor that can be measured on a scan.

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I have a solid tumor such as lung, breast, colorectal (without KRAS mutation), or head & neck cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability at RP2D of CPO301 as monotherapy

To determine the dose to be used in Part B (RP2D)

Secondary outcome measures

Efficacy assessment

Expression of anti-drug antibody (ADA)

Pharmacokinetics (PK)

Other outcome measures

Parts A and B, Exploratory: Correlatives

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B, Dose ExpansionExperimental Treatment1 Intervention

Participants receive CPO301 at the recommended phase 2 dose (RP2D) determined in Part A, administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.

Group II: Part A, Dose EscalationExperimental Treatment1 Intervention

Participants receive escalating doses of CPO301 of 0.6 mg/kg, 1.8mg/kg, 3.6 mg/kg, 4.8 mg/kg, 6.4 mg/kg and 8 mg/kg administered by IVI every 3 weeks (Q3W), with 21 days as a treatment cycle.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Conjupro Biotherapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

169 Total Patients Enrolled

Media Library

CPO301 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05948865 — Phase 1

Cancer Research Study Groups: Part A, Dose Escalation, Part B, Dose Expansion

Cancer Clinical Trial 2023: CPO301 Highlights & Side Effects. Trial Name: NCT05948865 — Phase 1

CPO301 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05948865 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of enrollment for this experiment?

"Correct. Clinicaltrials.gov has records of this clinical trial's commencement on June 6th 2023 and its most recent update on July 10th 2023, verifying that it is presently recruiting patients -102 to be exact- from a single medical facility."

Answered by AI

Has the FDA granted a seal of approval to Part A, Dose Escalation?

"Since this is a Phase 1 trial, and there is minimal data supporting safety and efficacy, Part A's Dose Escalation received an estimated score of 1."

Answered by AI

Are individuals currently being enlisted for this clinical trial?

"Affirmative. According to the information displayed on clinicaltrials.gov, this medical study is currently recruiting applicants. It was initially posted on June 6th 2023 and updated as recently as July 10th 2023. 102 patients are required for recruitment across one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors

2023. "A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948865.