This is a first-in-human, open-label, dose escalation and expansion, 2-part study to determine the safety, tolerability, and maximum tolerated dose of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available.
Part 1 is a dose-escalation study to establish the maximum tolerated dose based on dose-limiting toxicities and to evaluate the safety and tolerability of multiple doses of Andes-1537 for Injection in patients with advanced unresectable solid tumors that are refractory to standard therapy or for which no standard therapy is available. Part 2 is an open-label, dose-expansion study to determine the safety, tolerability, and preliminary efficacy of Andes-1537 in patients with advanced solid tumors. In part 2, patients will be enrolled and receive the recommended phase 2 dose established in part 1 based on the safety, tolerability, pharmacokinetics, and preliminary efficacy data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Part 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle
UCSF Medical Center at Mount Zion, Helen Diller Family Comprehensive Cancer Center, Early Phase Clinical Trials
San Francisco, California, United States
Incidence of dose-limiting toxicities
Determine maximum tolerated dose
Time frame: First 4-week treatment cycle
Adverse events
Incidence of treatment-emergent adverse events
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Safety laboratory tests
Changes in baseline safety laboratory tests
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Physical examinations
Changes in baseline physical examination
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Vital signs
Changes in baseline vital signs
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
12-lead electrocardiogram (ECG)
Changes in baseline ECG
Time frame: First 4-week treatment cycle
Injection site reactions
Incidence of injection site reactions
Time frame: Safety evaluations will be measured through 28 days after last dose of Andes-1537
Pharmacokinetic parameters in Andes-1537 in blood and urine for single-dose and multiple-dose evaluation
Measure maximum concentration, time to maximum concentration, area under the curve, clearance, volume of distribution, and half-life
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Time frame: Pre-treatment, following first dose and last dose of cycle 1 (4-week cycle), first dose of each additional cycle through study completion, and last visit
Pharmacodynamic parameters in blood and biopsy samples from accessible tissue
Evaluate biomarkers in tissue and blood
Time frame: Pre-treatment and at 4 and 8 weeks for biopsy; blood samples at pre-treatment, every 8 weeks, and last visit
Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) with CT or MRI scan
Changes in tumor size from baseline measurements
Time frame: Every 8 weeks following completion of 2 treatment cycles to cover from date of initiation until date of first documented progression or toxicity to Andes-1537, which ever comes first