A First in Human Study of PLT012 in Participants With Solid Tumor Cancers

Pilatus Biosciences Inc

Status and phase

Begins enrollment this month

Phase 1

Conditions

Solid Tumor Cancer

Advanced Malignant Solid Tumor

Treatments

Drug: PLT012

Study type

Interventional

Funder types

Industry

Identifiers

NCT07337525

PLT012-P1-001

Details and patient eligibility

About

The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are:

What adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug).

Participants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment.

For the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.

Full description

This study is a phase 1, open label, dose escalation study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged at least 18 years and provided written informed consent
Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)
Has at least one measurable lesion per RECIST v1.1
ECOG PS of 0 to 1
Life expectancy of ≥ 12 weeks
Child-Pugh score of Class A (for hepatocellular carcinoma only)
Adequate organ function as defined by protocol-specified laboratory values
Not pregnant or breastfeeding

Exclusion criteria

Insufficient washout period from prior therapies as defined in the study protocol
Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)
Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)
Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
Active or recent (within 3 years) autoimmune disease requiring medical treatment
Recipient of any organ transplant including allogeneic stem-cell transplant
Clinically significant and active cardiovascular disease
Known active alcohol or drug abuse
Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)