60 Participants NeededMy employer runs this trial

PD-32766D/T for Kidney Cancer

CL
Overseen ByClinical Lead
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with advanced kidney cancer that has returned or resisted other treatments. It uses a special pair of drugs, PD-32766D and PD-32766T, to identify and target cancer cells expressing a marker called CA9. The main goal is to determine the treatment's safety and behavior in the body, while also checking for any early signs of effectiveness against the cancer. Suitable candidates include those with clear cell renal cell carcinoma who have not responded to standard treatments and whose tumors show a positive reaction to the initial imaging test. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PD-32766T is being tested for safety and effectiveness in treating kidney cancer. In earlier studies, a similar compound, 64Cu-PD-32766, was well-tolerated by patients, with no serious side effects reported. This suggests the treatment might be safe for further testing.

As a Phase 1 trial, the primary goal is to assess the safety of PD-32766T in people. Although early results appear promising, the treatment remains in the early testing stages. Participants in this trial will help researchers understand any possible side effects and how well the treatment is tolerated at different doses.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PD-32766T for kidney cancer because it offers a new approach to treatment by using a unique imaging agent, PD-32766D, to first identify tumors that will respond to the therapy. Unlike traditional treatments such as surgery, radiation, and chemotherapy, which target cancer more generally, PD-32766T specifically targets tumors that show positive uptake of the imaging agent, potentially leading to more effective and personalized treatment. Additionally, this targeted approach may reduce side effects and improve outcomes by focusing therapy on responsive cancer cells.

What evidence suggests that PD-32766T might be an effective treatment for kidney cancer?

Research has shown that PD-32766T targets a protein called Carbonic Anhydrase IX (CA9), often found in kidney cancer cells. This protein helps cancer cells survive in low-oxygen areas. PD-32766T is designed to attach to these CA9-expressing cells and deliver a radioactive substance to kill them. In this trial, participants in the Phase 1a Dose Escalation arm will first receive PD-32766D for imaging, and those with positive tumor uptake will then receive PD-32766T. Participants in the Phase 1b Dose Expansion arm will receive PD-32766T at recommended dose levels. Although human studies have provided limited information, the treatment's mechanism shows promise in targeting and destroying cancer cells. Early signs suggest this method could be effective against clear cell renal cell carcinoma, a type of kidney cancer. More trials are needed to confirm its effectiveness and safety.678910

Are You a Good Fit for This Trial?

This trial is for adults with clear cell kidney cancer that has come back or not responded to treatment, and whose tumors show a marker called CA9. Participants must be able to undergo imaging tests and meet general health requirements.

Inclusion Criteria

Presence of positive tumor uptake
I am 18 years old or older.
I have advanced or metastatic clear cell kidney cancer after standard treatments.
See 4 more

Exclusion Criteria

I have a brain tumor that is not stable right now.
I have inflammatory bowel disease like Crohn's or ulcerative colitis.
I have bladder blockage or cannot control my urination.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo imaging with PD-32766D to assess CA9 expression

1 week
1 visit (in-person)

Phase 1a Treatment

PD-32766T is administered in escalating dose levels to determine safety and tolerability

6 weeks
Multiple visits (in-person) as per protocol

Phase 1b Treatment

Participants receive PD-32766T at the recommended dose to further evaluate safety and efficacy

6 months
Regular visits (in-person) as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PD-32766D
  • PD-32766T

Trial Overview

The study tests two related drugs: PD-32766D (used first as an imaging agent) and PD-32766T (a targeted therapy using radioactive particles). Only those whose tumors are positive on the scan will receive the therapy. The main goal is to check safety and early signs of effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 1b Dose ExpansionExperimental Treatment2 Interventions
Group II: Phase 1a Dose EscalationExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

PeptiDream Inc.

Lead Sponsor

Citations

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