Actively Recruiting
Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors
Led by Alyssum Therapeutics · Updated on 2025-05-02
85
Participants Needed
7
Research Sites
150 weeks
Total Duration
On this page
Sponsors
A
Alyssum Therapeutics
Lead Sponsor
C
CBCC Global Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.
CONDITIONS
Official Title
Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable or metastatic solid tumor refractory to standard therapy or no suitable standard therapy.
- At least one measurable lesion per RECIST version 1.1 for Part A; radiographically evaluable disease allowed after discussion.
- Recovery from prior chemotherapy adverse events to Grade 6 1 or baseline except alopecia.
- ECOG performance status of 0 to 2.
- Adequate bone marrow, renal, and hepatic function meeting specified laboratory values.
- Female patients of childbearing potential must have negative pregnancy test within 72 hours before first dose and each treatment cycle.
- Female patients of childbearing potential agree to use highly effective contraception during study and for 3 months after.
- Male patients with female partners of childbearing potential must use contraception or abstain during study and for 3 months after last dose.
- At least 30 days since participation in any other interventional clinical trial.
- At least 28 days since mRNA COVID-19 vaccination.
- Willingness to avoid sun exposure or use sun protection.
- Ability to understand and sign informed consent.
- For Part B dose expansion: metastatic triple-negative breast cancer patients with prior specified treatments and therapies as applicable.
You will not qualify if you...
- Uncontrolled or life-threatening symptomatic diseases or abnormalities affecting drug action or study participation.
- Unstable or severe uncontrolled medical or psychiatric conditions increasing risk.
- Uncontrolled diabetes.
- History of autoimmune diseases (exceptions apply).
- History or evidence of interstitial lung disease or active pneumonitis within 6 months.
- History or evidence of hemolysis or hemolytic anemia.
- History of adrenal gland disorders.
- Prior allogeneic bone marrow or solid organ transplantation.
- Uncontrolled endocrinopathy unless stable on hormone therapy.
- Known HIV infection or unresolved viral hepatitis.
- Significant cardiovascular disease or abnormalities including recent myocardial infarction, unstable angina, heart failure, arrhythmias, uncontrolled hypertension, or prolonged QT interval.
- Recent anticancer treatments or radiation within defined timeframes.
- Recent investigational agent use within 30 days or 5 half-lives.
- Major surgery within 4 weeks or not recovered from effects.
- Certain primary tumor types including untreated CNS malignancies, liquid tumors, lymphoma, or uveal melanoma.
- Active secondary malignancies requiring treatment.
- Systemic corticosteroid or immunosuppressive treatment within 14 days prior to treatment.
- History of severe immune-related adverse events leading to immunotherapy discontinuation.
- Recent severe immune-related adverse events within past 16 weeks.
- Recent live, attenuated, or mRNA vaccine within 28 days.
- Nursing women unwilling to stop breastfeeding during study and 3 months after.
- Uncontrolled active infection requiring IV antimicrobial medications within 14 days.
- Age under 18 years.
- Life expectancy less than 3 months.
- Known current drug or alcohol abuse.
- Any other condition deemed inappropriate for study participation by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
CBCC Global Research Site 001
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
CBCC Global Research Site 005
Bakersfield, California, United States, 93309
Actively Recruiting
3
CBCC Global Research Site 007
El Segundo, California, United States, 90245
Actively Recruiting
4
CBCC Global Research Site 008
Santa Monica, California, United States, 90403
Actively Recruiting
5
CBCC Global Research Site 003
Stanford, California, United States, 94305
Actively Recruiting
6
CBCC Global Research Site 002
Portland, Oregon, United States, 97239
Actively Recruiting
7
CBCC Global Research Site 006
Dallas, Texas, United States, 75230
Actively Recruiting
Research Team
B
Britney Barrera
CONTACT
E
Eldho Jose
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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