Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
250 participants
INTERVENTIONAL
2024-02-05
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part 1a: QTX3034 monotherapy dose-escalation
QTX3034 will be administered at protocol defined dose based on cohort assignment
QTX3034
QTX3034 will be administered at protocol defined dose
Part 1b: QTX3034 combination with cetuximab dose-escalation
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
QTX3034
QTX3034 will be administered at protocol defined dose
Cetuximab
Cetuximab will be administered at protocol defined dose.
Part 2: QTX3034 monotherapy dose-expansion
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
QTX3034
QTX3034 will be administered at protocol defined dose
Part 3: QTX3034 combination with cetuximab dose-expansion
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
QTX3034
QTX3034 will be administered at protocol defined dose
Cetuximab
Cetuximab will be administered at protocol defined dose.
Interventions
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QTX3034
QTX3034 will be administered at protocol defined dose
Cetuximab
Cetuximab will be administered at protocol defined dose.
Eligibility Criteria
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Inclusion Criteria
* Part 1: - Advanced solid tumors with at least 1 prior systemic therapy
* Evaluable or Measurable disease per RECIST 1.1.
* Parts 2 and 3: Measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate organ function
Exclusion Criteria
* Active brain metastases or carcinomatous meningitis
* History of other malignancy within 2 years
* Significant cardiovascular disease
* Disease or disorder that may pose a risk to patient's safety
18 Years
ALL
No
Sponsors
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Quanta Therapeutics
INDUSTRY
Responsible Party
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Locations
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UCLA Hematology/Oncology
Los Angeles, California, United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
NYU Langone Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
SCRI- Nashville
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
START San Antonio, LLC
San Antonio, Texas, United States
University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Jenna Davis
Role: primary
Front Desk
Role: primary
Ingrid Palma
Role: primary
Carly Taylor
Role: primary
Kaela D. Malone-Larry
Role: primary
Jovica Gasic
Role: backup
DL_Phase1Screening
Role: primary
Gunnar Lauer
Role: primary
Sabina Wlazlo
Role: primary
Michelle Johnson
Role: primary
Lana Seibert
Role: backup
askSarah
Role: primary
Ly Nguyen
Role: primary
Isabel Jimenez, RN, MSN
Role: primary
Susan Sharry
Role: primary
Blake Patterson
Role: primary
Other Identifiers
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QTX3034-001
Identifier Type: -
Identifier Source: org_study_id