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A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

NCT03267316 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2024-08-22

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, and preliminary antitumor activity of CAN04 both as a monotherapy and in combination with standard of care treatment in subjects with solid cancer tumors.

Following completion of the first part, the dose escalation cohorts, and determination of maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as monotherapy or in combination with the standard of care treatment and to identify the RP2D of CAN04 in combination with standard of care. In addition, early signs of efficacy during treatment with CAN04 will be investigated.

Conditions

Interventions

BIOLOGICAL

CAN04

A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.

DRUG

Cisplatin

Standard of care treatment

DRUG

Gemcitabine

Standard of care treatment

DRUG

Nab-paclitaxel

Standard of care treatment

DRUG

Carboplatin

Standard of care treatment

DRUG

Pemetrexed

Standard of care treatment

Sponsors & Collaborators

  • Cantargia AB

    lead INDUSTRY

Principal Investigators

  • Ahmad Awada, Professor · Jules Bordet Institute, Brussels, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2024-03-14
Completion
2024-03-14

Countries

  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Germany
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Spain
  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03267316 on ClinicalTrials.gov