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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

S

Shenzhen Ionova Life Sciences

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Advanced Metastatic Castration Resistant Prostate Cancer

Treatments

Drug: INV-9956

Study type

Interventional

Funder types

Industry

Identifiers

NCT06609005
INV-9956-101

Details and patient eligibility

About

This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC.

Full description

This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC.

The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion. The screening period for all phases is up to 28 days, and one treatment cycle is 28 days.

The investigational drug will be co-administered with once daily (QD) dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg as corticosteroid replacement therapy.

Read more

Enrollment

84 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Written informed consent obtained.
  2. Male aged ≥ 18 years.
  3. Histologically confirmed adenocarcinoma of the prostate.
  4. Castration resistant prostate cancer with serum testosterone <50 ng/dL.
  5. Metastatic disease.
  6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
  7. Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.
  8. ECOG performance status 0-1.
  9. Adequate marrow, liver and kidney function.
  10. INR ≤1.5.
  11. Able to swallow study treatment.
  12. Has a life expectancy of > 3 months.

Exclusion criteria

  1. 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.
  2. History of pituitary or adrenal dysfunction.
  3. Poorly controlled diabetes mellitus.
  4. Clinically significant abnormality in serum potassium and sodium.
  5. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
  6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
  7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
  8. Prolonged QTcF interval.
  9. Active infection or other medical condition that would make corticosteroid contraindicated.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

84 participants in 8 patient groups

Phase 1 INV-9956 Dose escalation Dose level 1
Experimental group
Description:
INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 1 INV-9956 Dose escalation Dose level 2
Experimental group
Description:
INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 1 INV-9956 Dose escalation Dose level 3
Experimental group
Description:
INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 2 INV-9956 Dose expansion - Cohort A
Experimental group
Description:
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 2 INV-9956 Dose expansion - Cohort B
Experimental group
Description:
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4
Experimental group
Description:
INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5
Experimental group
Description:
INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956
Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6
Experimental group
Description:
INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate
Treatment:
Drug: INV-9956

Trial contacts and locations

8

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Central trial contact

Yi Zhu, MD, MBA

Data sourced from clinicaltrials.gov

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