Authorised Human Pharmacology (Phase I)- Other Advanced Renal Cell Carcinoma

A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination with Axitinib in Subjects with Advanced Renal Cell Carcinoma

EU CTIS ID: 2023-509604-15-00

What this study is testing

Safety: Determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of MEDI5752 combined with lenvatinib (Dose-exploration Phase) Assess safety and tolerability of MEDI5752 combined with lenvatinib (or axitinib) Efficacy: Assess the antitumor activity of MEDI5752 combined with lenvatinib"

  • Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • "1. Age ≥ 18 at the time of screening 2. Body weight > 35 kg 3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures 4. Histologically or cytologically proven advanced RCC with clear cell component 5. Advanced RCC not previously treated in that setting 6. Provision of tumor material (≥ 5 unstained slides or tissue block) from an archival or fresh tissue biopsy 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Subjects must have at least 1 measurable lesion according to RECIST v1.1 9. Life expectancy ≥ 12 weeks 10. Adequate organ and marrow function (in the absence of transfusions or growth factor support within 14 days prior to enrollment) as defined 11. Female subjects of childbearing potential: (a) Must have negative pregnancy test at screening and prior to each administration of investigational product (b) If sexually active with a nonsterilized male partner, must use at least one highly effective method of birth control from screening to 3 months (ie, 90 days; based on 5 half-lives of MEDI5752 + 6 months) after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib. 12. Female subjects must not breastfeed and must not donate, or retrieve for their own use, ova from screening to 3 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib. 13. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 3 months (90 days) after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.

You likely can't join if

  • "1. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results 2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study 3. Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitors 4. Previous treatment with VEGF inhibitors 5. Evidence of infections as defined 6. History of organ transplant 7. Active or prior documented autoimmune or inflammatory disorders 8. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of investigational product with listed exceptions to this criterion 9. Poorly controlled blood pressure (BP), defined as BP >= 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1. 10. Thromboembolic (arterial or venous) events within previous 6 months 11 Any concurrent therapy for cancer including, but not limited to, prohibited medications as listed 12 Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product 13. Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression 14. History of another primary malignancy exception 15. Major surgery within 4 weeks prior to enrollment or radiation therapy within 2 weeks prior to enrollment, or has not recovered (ie, ≤- Grade 1 or at baseline) from AEs due to prior treatment 16. Female subjects who are pregnant or breastfeeding as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control as described 17. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted 18. Uncontrolled intercurrent illness within the last 6 months prior to enrollment including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure (class > 2 as defined by New York Heart Association), uncontrolled hypertension, unstable angina pectoris, history of myocardial infarction, cardiac arrhythmia, interstitial lung disease, serious chronicgastrointestinal conditions associated with diarrhea 19. Uncontrolled intercurrent illness within the last 6 months prior to enrollment including psychiatric illness/social situations that would limit subject's compliance with study requirements, substantially increase subject's risk of incurring AEs or compromise subject's ability to give informed consent 20. Clinically significant gastrointestinal abnormality including: (a) Malabsorption, gastric resection, or any condition that according to investigator might affect absorption of orally taken medication (b) Active gastrointestinal bleeding in past 3 months (c) History of gastrointestinal perforation or gastrointestinal or non-gastrointestinal fistula in past 3 months 21. Serious nonhealing wound, ulcer, or bone fracture 22. Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of investigational product. 23. Radiographic evidence of major blood vessel invasion/infiltration/encasement"

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.