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A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors

PHASE1RECRUITING

This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.

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Study details:

The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Patients must be at least 18 years of age at the time of signing the informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective.

Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Adequate baseline organ function and hematologic function.

Life expectancy >3 months.

Exclusion criteria

Systemic anti cancer therapy within 4 weeks of first dose of study drug.

Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.

Uncontrolled intercurrent illnesses.

Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-14

Primary completion: 2025-04-28

Study completion finish: 2025-08-30

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06533332

Intervention or treatment

DRUG: ERX-315

Conditions

• Advanced Solid Tumor
• Metastatic Breast Cancer
• Metastatic Ovarian Cancer
• Metastatic Endometrial Cancer
• Metastatic Liver Cancer
• Metastatic Pancreatic Cancer

Condition: Advanced Solid Tumor, Metastatic Breast Cancer and more
DRUG: ERX-315
Sydney, New South Wales, Australia
Sponsor: EtiraRx Australia Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Kinghorn Cancer Center

Research sites nearby

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The Kinghorn Cancer Center
Sydney, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ERX-315 Active investigational therapy	DRUG: ERX-315 Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of Dose Limiting Toxicities of ERX-315	First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug	21 days
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315	Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.	84 days
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315	Laboratory abnormalities as characterized by type, frequency, severity, and timing.	84 days
Determination of the recommended phase 2 dose	To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors	84 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).	AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug	21 days
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)	Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug	21 days
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)	t1/2 will be assessed after single and multiple doses of drug	21 days
Antitumor activity of ERX-315 based on Objective response rate (ORR)	ORR will be assessed by RECIST v1.1	84 days
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)	BOCR will be assessed by RECIST v1.1	84 days
Antitumor activity of ERX-315 based on Duration of response (DOR)	DOR will be assessed by RECIST v1.1 and time frame of response	84 days
Antitumor activity of ERX-315 based on Progression-free survival (PFS)	PFS will be assessed by RECIST v1.1 and time frame of response	84 days

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors