Trial Title:
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
NCT ID:
NCT06150664
Condition:
Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Hodgkin Lymphoma
Head and Neck Squamous Cell Carcinoma
Malignant Melanoma
Conditions: Official terms:
Melanoma
Triple Negative Breast Neoplasms
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CTX-8371
Description:
Intravenous (IV) infusion (0.1-10.0 mg/kg) every two weeks.
Arm group label:
Dose Escalation Cohort 1
Arm group label:
Dose Expansion Cohort 2
Summary:
This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a
monotherapy in patients with metastatic or locally advanced malignancies. The study will
be conducted in 2 cohorts: Dose Escalation and Dose Expansion.
Detailed description:
This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability,
immunogenicity, and pharmacokinetic profile of CTX-8371 monotherapy. Preliminary
anti-tumor activity of CTX-8371 will also be assessed. The study will be conducted in 2
cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a
3+3 design to evaluate five dose levels (0.1-10 mg/kg) of CTX-8371 given as an IV
infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-8371
as an IV infusion at a dose(s) based on data from the Dose Escalation Cohort.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Patients must have a histologically or cytologically confirmed diagnosis of locally
advanced unresectable or metastatic disease that is relapsed/refractory to standard
therapy or for which no effective standard therapy is available, including
1. Malignant Melanoma (MM)
- Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1
treatment. Study enrollment (C1D1) must be within 12 weeks of the last
dose of the anti-PD-1/PD-L1 blocking antibody.
- Patients must have had prior testing for BRAF V600 mutations.- Patients
with BRAF V600 activating mutation must have received prior therapy with a
BRAF/MEK inhibitor.
- Uveal and mucosal melanoma are excluded.
2. Head and Neck squamous cell carcinoma (HNSCC)
- HNSCC of oral cavity, oropharynx, hypopharynx, or larynx
- Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1
treatment. Study enrollment (C1D1) must be within 12 weeks of the last
dose of the anti-PD-1/PD-L1 blocking antibody.
- Patients must have received prior treatment with platinum-based
chemotherapy.
3. Non-Small Cell Lung Cancer (NSCLC)
- Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1
treatment. Study enrollment (C1D1) must be within 12 weeks of the last
dose of the anti-PD-1/PD-L1 blocking antibody.
- Patients must have received prior treatment with platinum-based
chemotherapy.
4. Triple Negative Breast Cancer (TNBC)
- ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO
Allison et al 2020).
- Patients with HER2-low cancers (IHC 1+ or FISH-negative) are excluded.
- Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10%
by CPS pembrolizumab with chemotherapy.
5. Classical Hodgkin Lymphoma (HL)
- Patients must have received at least two prior systemic therapies
including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor
- Patients must have experienced less than a CR (according to Lugano
criteria to anti- PD-1 treatment
3. Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST
1.1. Patients with HL must have at least one measurable lesion > 1.5 cm for nodal, >
1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor
sites that are considered measurable must not have received prior radiation
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L,
platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without
transfusion)
6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤
2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
7. Adequate renal function defined as creatinine clearance ≥ 30mL/min by
Cockcroft-Gault equation
8. Female patients must be surgically sterile (or have a monogamous partner who is
surgically sterile) or be at least 2 years postmenopausal or commits to use 2
acceptable forms of birth control (defined as the use of an intrauterine device
(IUD), a barrier method with spermicide, condoms, any form of hormonal
contraceptives) or abstinence for the duration of the study and for 4 months
following the last dose of study treatment. Male patients must be sterile
(biologically or surgically) or commit to the use of a reliable method of birth
control (condoms with spermicide) for the duration of the study and for 4 months
following the last dose of study treatment.
9. Female patients who are women of childbearing potential (WOCBP) must have a negative
serum pregnancy test at Screening within 7 days of dosing with CTX-8371
10. Last dose of previous PD-1 or PD-L1 therapy ≥ 28 days, other anticancer therapy > 21
days (or 2 half-lives for proteins, whichever is longer), radiotherapy >21 days
(concurrent localized palliative radiotherapy is allowed during CTX-8371 treatment),
or surgical intervention >21 days prior to the first dose of CTX-8371
11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2
12. Capable of understanding and complying with protocol requirements
13. Signed and dated institutional review board (IRB)/independent ethics committee
(IEC)-approved informed consent form (ICF) before any protocol-directed screening
procedures are performed
Exclusion Criteria:
1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy,
including immune related adverse reactions, which led to discontinuation of
treatment
2. Systemic therapy with immunosuppressive agents within 7 days before the start of
CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and
physiologic replacement for patients with adrenal insufficiency are allowed
3. Patient is a pregnant or lactating WOCBP
4. Prior organ transplantation
5. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or
human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or
detectable HBV DNA are eligible only if adequately controlled on antiviral therapy
according to institutional standards and liver function eligibility criteria are
also met. HCV patients showing sustained viral response or patients with immunity to
HBV infection may enroll.
6. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., >
10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a
prior history of autoimmune disease may be eligible following discussion with the
Medical Monitor
7. Other medical condition that in the opinion of the Investigator and/or Sponsor
Medical Monitor may interfere with the conduct and/or interpretation of the current
study, including:
1. Congestive heart failure (> New York Heart Association Class II), active
coronary artery disease, unevaluated new onset angina within 3 months or
unstable angina (angina symptoms at rest) or clinically significant cardiac
arrhythmias
2. QTc interval (using Fridericia correction calculation) > 480 msec
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
D&H Cancer Research Center
Address:
City:
Margate
Zip:
33063
Country:
United States
Status:
Recruiting
Contact:
Last name:
Camila Linares
Email:
clinares@dhnrc.com
Investigator:
Last name:
Emilio P Araujo-Mino, MD
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - Lake Nona
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Gilmore
Phone:
904-380-2410
Email:
elizabeth.griffith@scri.com
Investigator:
Last name:
Cesar Perez Batista, MD
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists - Sarasota
Address:
City:
Sarasota
Zip:
34236
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Judy Wang, MD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kailene Sullivan, RN
Phone:
617-632-3482
Email:
Kailene_sullivan@dfci.harvard.edu
Investigator:
Last name:
Patrick Ott, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
ASKRPCI
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Shipra Gandhi, MD
Email:
Principal Investigator
Start date:
March 19, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Compass Therapeutics
Agency class:
Industry
Source:
Compass Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150664
