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A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors

A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours

NCT05116891•Cantargia AB

View on ClinicalTrials.gov

Summary

This is a Phase 1/2, open-label, multicentric, non-randomised, parallel-arm study that aims to establish the safety, tolerability, and initial efficacy of CAN04 in combination with 3 SoC chemotherapies (mFOLFOX, DTX, and G/C).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•PHASE 1 and PHASE 2:
•Subject must be able to understand and sign written informed consent, according to local guidelines.
•Subject must be ≥18 years of age at the time of signature of the ICF.
•Subject must have an ECOG PS score of 0 or 1.
•Subject must have adequate organ function, as indicated by the laboratory values in the protocol
•Women of childbearing potential must have a negative serum pregnancy test before study entry. Women of non-childbearing potential will have had at least 24 continuous months of natural (spontaneous) amenorrhea, and an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms), or have had hysterectomy, bilateral salpingectomy or bilateral oophorectomy\>6 weeks before screening.
•Male or female subjects: Male subjects with female partners of childbearing potential and female subjects of childbearing potential are required to use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 4 months after the last dose of CAN04 or for 6 months after the last dose of the relevant chemotherapies, whatever is longer. Male subjects must also refrain from donating sperm during their participation in the study and in the period when contraceptives are required
•Subjects must not have contraindications according to the approved local summary of product characteristics (SmPC) for the respective components of the SoC chemotherapies.
•PHASE 1 (Dose Escalation)
•Subject has histologically or cytologically confirmed diagnosis of locally advanced cancer or metastatic cancer. Subjects do not need to have measurable disease per response evaluation criteria in solid tumours (RECIST) v1.1.
+27 more criteria

Exclusion Criteria

•* G/C Arm: All subjects eligible for G/C can be enrolled (including first-line treatments).. Subjects with BTC will be prioritized.
•PHASE 2 All treatment arms in Phase 2 (CRC, NSCLC or BTC)
•Subject must have at least 1 measurable lesion as defined by RECIST v1.1. Tumour lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated.
•Only applicable after the second interim analysis has been performed: Primary or metastatic lesion amenable to biopsy and willingness of the subject to undergo a screening (if no adequate archival tissue is available) and an on-treatment biopsy (as defined in the protocol). The lesion accessible for biopsy may not be the only target lesion and should not be located in a previously irradiated field (unless this index lesion has PD ≥20% after radiation). The requirement(s) for the screening and/or on-treatment biopsy and/or archival tissue may be waived by the sponsor for individual sites and subjects, in particular if tumour locations are not safely accessible, after discussion and documented agreement between the site and the sponsor´s medical monitor.
•CRC Arm
•Subject has definitive histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the colon or rectum without possibility of locoregional treatment with curative intention or candidate for curative metastasectomy
•Subject has received at least 2 prior lines of therapy for non-resectable locally advanced or metastatic CRC and has progressed or is intolerant to those therapies. If the tumour is microsatellite instability-high, it should have progressed on a previous immune CPI unless contraindicated, or such therapy is not available to the subject. Subjects with KRAS wildtype should be eligible to receive mFOLFOX and should have received anti-EGFR therapy unless contraindicated or not available for the subject.
•Note: For subjects who received adjuvant or neoadjuvant chemotherapy and had recurrence within 6 months of completion of the adjuvant or neoadjuvant chemotherapy, the adjuvant or neoadjuvant therapy is counted as the first line of chemotherapy for the metastatic disease.
•NSCLC Arm
•Subject has histologically or cytologically confirmed squamous or non-squamous NSCLC unresectable stage IIIB/C or stage IV for whom monotherapy DTX treatment is indicated.
+14 more criteria

Locations (6)

EDOG Institut de Cancerologie de l'Ouest - PPDS

Saint-Herblain, Boulevard Jacques Monod, France

Centre Georges François Leclerc

Dijon, Côte-d'Or, France

Institut Bergonie

Bordeaux, France

Centre Eugene Marquis

Rennes, France

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Key Dates

Start Date

September 22, 2021

Primary Completion Date

June 23, 2023

Completion Date

June 23, 2023

Last Updated

July 3, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorsColorectal CancerNon Small Cell Lung CancerBiliary Tract Cancer

Interventions

CAN04 (nadunolimab)

DRUG

mFOLFOX

DRUG

DTX

DRUG

G/C

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)