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Monoclonal Antibodies

CTIM-76 for Ovarian Cancer

Phase 1
Recruiting
Research Sponsored by Context Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer
ECOG 0, 1, or 2
Must not have
Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression
Prior treatment with CLDN-6 targeted therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of ctim-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Awards & highlights

Summary

This trial is testing a new drug called CTIM-76 in patients with ovarian cancer and other types of solid tumors that have not responded to platinum-based treatments. The study aims to determine the safety and

Who is the study for?
This trial is for individuals with recurring ovarian cancer or other advanced solid tumors that are resistant to platinum-based treatments. Participants must have a tumor that tests positive for CLDN6, which the study drug targets.
What is being tested?
The trial is testing CTIM-76, a new type of antibody designed to target and engage T cells against tumors. It's in early stages (Phase 1) where researchers are figuring out the right dose and checking how well it works on different cancers like ovarian, testicular, and endometrial.
What are the potential side effects?
As this is an early-stage trial for CTIM-76, specific side effects aren't listed yet but may include typical reactions to immune therapies such as fatigue, fever, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is CLDN6 positive and resistant to platinum-based treatments.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have previously been treated with CLDN-6 targeted therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of ctim-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of ctim-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Dose Limiting Toxicities (DLTs)
Overall response rate (ORR)

Side effects data

From 2014 Phase 2 trial • 21 Patients • NCT00560794
100%
Pyrexia
67%
Blood immunoglobulin A decreased
62%
Blood immunoglobulin G decreased
48%
Blood immunoglobulin M decreased
48%
Hypokalaemia
48%
Headache
43%
Chills
38%
Fatigue
38%
Oedema peripheral
33%
Leukopenia
33%
Nasopharyngitis
33%
Weight increased
29%
Thrombocytopenia
29%
C-reactive protein increased
29%
Back pain
29%
Lymphopenia
24%
Diarrhoea
24%
Nausea
24%
Gamma-glutamyltransferase increased
24%
Growing pains
24%
Dizziness
24%
Tremor
24%
Insomnia
24%
Haematuria
24%
Dyspnoea
24%
Rash
24%
Hypotension
19%
Tachycardia
19%
Constipation
19%
Alanine aminotransferase increased
19%
Fibrin D dimer increased
19%
Weight decreased
19%
Hyperglycaemia
19%
Periorbital oedema
14%
Vomiting
14%
Blood potassium decreased
14%
Cough
14%
Hyperhidrosis
10%
Bradycardia
10%
Lacrimation increased
10%
Dry mouth
10%
Catheter site erythema
10%
Catheter site pain
10%
Immunodeficiency
10%
Bronchitis
10%
Cystitis
10%
Oral herpes
10%
Pharyngitis
10%
Sinusitis
10%
Blood alkaline phosphatase increased
10%
Blood lactate dehydrogenase increased
10%
Coagulation factor XIII level increased
10%
Immunoglobulins decreased
10%
Monocyte count increased
10%
Anorexia
10%
Arthralgia
10%
Myalgia
10%
Neck pain
10%
Pain in extremity
10%
Night sweats
10%
Hypertension
5%
Convulsion
5%
Epilepsy
5%
Somnolence
5%
Syncope
5%
Bacterial sepsis
5%
Bronchopneumonia
5%
Catheter related infection
5%
Escherichia sepsis
5%
Medical device complication
5%
Thrombosis in device
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab

Trial Design

1Treatment groups
Experimental Treatment
Group I: CTIM-76Experimental Treatment1 Intervention
Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts. Phase 1b: Dose Expansion - 30 subjects will be evaluated using 2 different doses of CTIM-76

Find a Location

Who is running the clinical trial?

Context Therapeutics Inc.Lead Sponsor
5 Previous Clinical Trials
126 Total Patients Enrolled
Claudio Dansky Ullmann, MDStudy ChairContext Therapeutics Inc.
2 Previous Clinical Trials
28 Total Patients Enrolled
~53 spots leftby Jul 2027
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