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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

ConditionAdvanced Metastatic Castration Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorShenzhen Ionova Life Sciences Co., Ltd.

About this trial

This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained.

Male aged ≥ 18 years.

Histologically confirmed adenocarcinoma of the prostate.

Castration resistant prostate cancer with serum testosterone <50 ng/dL.

Disqualifiers

Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.

History of pituitary or adrenal dysfunction.

Poorly controlled diabetes mellitus.

Clinically significant abnormality in serum potassium and sodium.

Trial design

Design model

Sequential

Treatments tested in this trial

  • INV-9956

    Drug

    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate

Treatment groups

84 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Phase 1 INV-9956 Dose escalation Dose level 1Experimental treatment 1 intervention
Group B: Phase 1 INV-9956 Dose escalation Dose level 2Experimental treatment 1 intervention
Group C: Phase 1 INV-9956 Dose escalation Dose level 3Experimental treatment 1 intervention
Group D: Phase 2 INV-9956 Dose expansion - Cohort AExperimental treatment 1 intervention
Group E: Phase 2 INV-9956 Dose expansion - Cohort BExperimental treatment 1 intervention
Group F: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4Experimental treatment 1 intervention
Group G: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5Experimental treatment 1 intervention
Group H: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Maximum tolerated dose (MTD)

The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.

Time frame
Within first 28 days of treatment
2

Phase 1: Recommended dose range (RDR)

The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-9956, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1

Time frame
12 months
3

Phase 2: Evaluate Radiographic progression-free survival (rPFS)

To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)

Time frame
12 months
4

Phase 2: Evaluate overall response rate (ORR)

To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)

Time frame
12 months

Secondary outcomes

1

Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0

To analyze the safety profile of INV-9956 as a single agent by AE, clinical lab test results, ECG and Vital signs changes

Time frame
12 months
2

Phase 1: Determine the PK using AUC of INV-9956

To determine the pharmacokinetics (PK) using AUC of INV-9956 after a single dose and at steady state after multiple doses

Time frame
12 months
3

Phase 1: Determine the PK using Cmax of INV-9956

To determine the pharmacokinetics (PK) using Cmax of INV-9956 after a single dose and at steady state after multiple doses

Time frame
12 months
4

Phase 1: Determine the blood concentration of steroid hormone

To determine the blood concentration of steroid hormones at various timepoints as PD markers for INV-9956

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Ionova Life Sciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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