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Checkpoint Inhibitor

IMC-C103C + Atezolizumab for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Immunocore Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to approximately 2 years
Awards & highlights

Study Summary

This trial is designed to test a new cancer treatment called IMC-C103C. The treatment is for adults whose cancer is positive for the tumor-associated antigen MAGE-A4 and who have the appropriate HLA-A2 tissue marker. The trial is to test the safety and efficacy of IMC-C103C.

Who is the study for?
This trial is for adults with certain advanced solid tumors that are positive for MAGE-A4 and have the HLA-A2 tissue marker. Participants should be relatively fit (ECOG PS 0 or 1), have measurable disease, and must not be responding to standard treatments. They need to use effective contraception if applicable, and cannot join if they're pregnant, breastfeeding, have active infections requiring antibiotics, HIV/HBV/HCV, are on immunosuppressants, or have serious heart issues.Check my eligibility
What is being tested?
The trial is testing IMC-C103C alone and combined with Atezolizumab in patients whose cancer cells express a specific protein called MAGE-A4. It's designed to see how safe these treatments are and how well they work against such cancers. This is the first time humans will receive IMC-C103C.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to activation of T-cells by IMC-C103C which could affect normal tissues/organs. Atezolizumab can cause similar immune responses as well as fatigue, nausea, fever among others; however individual experiences may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Incidence of dose-limiting toxicities (DLT)
Phase 1: changes in electrocardiogram parameters
Phase 1: changes in laboratory parameters
+4 more
Secondary outcome measures
Changes in lymphocyte counts over time
Changes in serum cytokines over time
Duration of response
+14 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

4Treatment groups
Experimental Treatment
Group I: IMC-C103C monotherapy SC dose escalationExperimental Treatment1 Intervention
Patients will be enrolled n=9-12 to establish the MTD/expansion dose
Group II: IMC-C103C and atezolizumab dose escalationExperimental Treatment2 Interventions
n=approximately 12 patients to establish the MTD/expansion dose
Group III: IMC-C103C - expansionExperimental Treatment1 Intervention
Patients will be enrolled n=9-24 per expansion cohort (up to 4 total): metastatic/unresectable tumors of interest patients treated at the expansion dose of IMC-C103C to assess preliminary anti-tumor efficacy
Group IV: IMC-C103C - Monotherapy IV dose escalationExperimental Treatment1 Intervention
n= approximately 50 patients to establish the MTD/expansion dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor
13 Previous Clinical Trials
3,694 Total Patients Enrolled
Mohammed Dar, MDStudy DirectorImmunocore Ltd
3 Previous Clinical Trials
951 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03973333 — Phase 1 & 2
Solid Tumors Research Study Groups: IMC-C103C - Monotherapy IV dose escalation, IMC-C103C - expansion, IMC-C103C monotherapy SC dose escalation, IMC-C103C and atezolizumab dose escalation
Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03973333 — Phase 1 & 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03973333 — Phase 1 & 2

Frequently Asked Questions

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

What is the geographic scope of this research endeavor?

"This clinical trial is being administered at the University of Colorado Cancer Center in Aurora, UPMC Cancer Center in Pittsburgh, and University of California Davis Comprehensive Cancer Centre in Sacramento. Additionally, there are 9 other study sites across the United States."

Answered by AI

How extensive is the pool of participants in this experiment?

"In order to proceed with this trial, 144 eligible participants are required. Those interested may join from medical centres including the University of Colorado Cancer Center in Aurora or the University of California Davis Comprehenvise Cancer Centre in Sacramento."

Answered by AI

Has IMC-C103C been explored in any other studies of a similar nature?

"Initial research on IMC-C103C was conducted in 2008 by the team at SCRI Tennessee Oncology Chattanooga. Over 80 clinical trials have already been completed and there are currently 351 active studies, primarily focused around Aurora Colorado."

Answered by AI

Are there any vacancies available for enrollees in this research?

"Yes, according to the information posted on clinicaltrials.gov, this study is in need of participants and was first made available on May 17th 2019. The most recent update occurred March 10th 2022 and 144 people are being recruited from 9 sites."

Answered by AI

Is this investigation a pioneering endeavor?

"IMC-C103C has been studied since 2008 when Hoffmann-La Roche sponsored a clinical trial with 720 patients. This initial research granted the drug its Phase 2 approval. Currently, 351 trials for IMC-C103 are being conducted in 1646 cities across 74 countries."

Answered by AI

What therapeutic effects does IMC-C103C typically offer?

"IMC-C103C is typically prescribed to combat small cell lung cancer, but it also has the potential to be effective against malignant neoplasms, non-small cell lung carcinoma and postoperative conditions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab
2019. "Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03973333.
~13 spots leftby Apr 2025
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