An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.
Summary
This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Arms & interventions
- BiologicalIPN60300
IPN60300 will be administered at assigned dose level.
Outcome measures
Primary
Phase Ia: Percentage of participants with dose limiting toxicity (DLT)
Time frame: within 21 days following study drug administration.
Phase Ia and Ib: Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TE SAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is an AE for which the start date is on or after the date that the intervention began or it was present prior to receiving the intervention but the intensity increased during the active phase of the study.
Time frame: From the first IPN60300 administration until 30 days after the last dose
Phase Ib: Objective response rate (ORR)
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as determined by investigator per RECIST version 1.1
Time frame: At end of study (up to approximately 3 years )
Secondary
Phase Ia: Time to maximum observed drug concentration (tmax) of IPN60300 after single and multiple doses of IPN60300
Time frame: within 21 days following study drug administration
Phase Ia: Maximum observed drug concentration (cmax) of IPN60300 after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration
Phase Ia: Area under the plasma concentration time curve over one dosing interval (AUCtau) of IPN60300 after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration
Phase Ia: Tmax of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Cmax of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: AUCtau of Total Antibody after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Tmax of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: Cmax of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia: AUCtau of free toxin after single and multiple doses of IPN60300
Time frame: Within 21 days following study drug administration.
Phase Ia and Ib: Percentage of Treatment-Emergent Anti-Drug Antibodies (ADA), Including Binding and Neutralizing Antibodies.
Time frame: Prior study drug administration until the End of Treatment (EoT) visit (approximately up to 3 years
Phase Ia: Objective Response Rate (ORR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Duration of response (DoR)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Progression-free survival (PFS)
Time frame: At end of study (up to approximately 3 years)
Phase Ib: Disease control rate (DCR)
Time frame: At end of study (up to approximately 3 years)
Eligibility criteria
Study locations (6)
Yale Cancer Center-Yale University
New Haven, Connecticut, 06510
START Midwest
Grand Rapids, Michigan, 49546
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
San Antonio, Texas, 78229
NEXT Oncology
Fairfax, Virginia, 22031