Clear Cell Renal Cell CarcinomaPhase 1NCT07688187
A Study of Theranostic Pair PD-32766D/T in Participants With Carbonic Anhydrase IX Positive Clear Cell Renal Cell Carcinoma
A Phase 1 study testing PD-32766D (a Copper-64 [64Cu] labeled peptide) and PD-32766T (an Actinium-225 [225Ac] labeled peptide) in people with Clear Cell Renal Cell Carcinoma, run by PeptiDream Inc. at 1 site in United States.
Trial summary
This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase IX (CA9)-expressing clear cell renal cell carcinoma (ccRCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- PD-32766D (a Copper-64 [64Cu] labeled peptide) and PD-32766T (an Actinium-225 [225Ac] labeled peptide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged ≥18 years.
- Participants with confirmed diagnosis of ccRCC will be included based on the following characteristics:
- Histological confirmed locally advanced, unresectable, or metastatic ccRCC, after all available standard therapy.
- Presence of evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) guideline (defined by RECIST v1.1).
- Presence of positive tumor uptake
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- The participant's with adequate organ function
- Life expectancy of at least 12 weeks as assessed by the Investigator.
Who cannot join
- Concurrent serious (as determined by the Investigator), uncontrolled medical conditions, or life-threatening or other significant comorbid conditions.
- Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic, investigational or hormonal therapy for treatment of solid tumors within 28 days.
- Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy.
- Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months.
- Any previous CA9 targeting treatment.
- Known hypersensitivity to the active substance or to any of the excipients of the PD-32766D and or T.
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- Clinically unstable CNS tumor at the time of screening.
- History of bowel perforation or bowel infarction, history of active stomach or duodenum ulcer or fistula in the last 2 years, history of gastroesophageal reflux disease or enterocolitis Grade ≥3 according to NCI-CTCAE and/or known active gastrointestinal infection, any unresolved prior radiation-induced gastrointestinal injury.
- Acute infection requiring IV antibiotics, antivirals, or antifungals within 14 days prior to the initiation of treatment (oral treatment are allowed).
- Pregnant or breastfeeding women.
- Known active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Have been diagnosed with another primary malignancy.
- Have significant, uncontrolled, or active cardiovascular disease
- Bladder outflow obstruction or unmanageable urinary incontinence.
- Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Any major surgery within 12 weeks before enrolment.
- History of psychiatric illness or social situations likely to interfere with ability to comply with protocol required assessment or give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Research site
Omaha, Nebraska, 68130
Site Contact
About this study
Official title: An Open-Label, Multicenter, Phase 1a/1b, Dose Escalation/Dose Expansion Clinical Trial of Theranostic Pair PD-32766D, a 64Cu-Labeled Peptide and PD-32766T, an 225Ac-Labeled Peptide Targeting Carbonic Anhydrase IX in Adult Participants With Relapsed or Refractory Clear Cell Renal Cell Carcinoma Who Have Progressed From or Could Not be Administered Due to Medical Unsuitability or Limited Access to All Standard of Care Therapies
This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase IX (CA9)-expressing clear cell renal cell carcinoma (ccRCC). The primary objective is to evaluate the safety and tolerability of PD-32766T, and to characterize its pharmacokinetics and preliminary antitumor activity.
Participants will first undergo imaging with PD-32766D to assess CA9 expression. Subjects with positive tumor uptake will be eligible to receive PD-32766T. In Phase 1a, PD-32766T will be administered in an escalating dose levels and schedule determined according to protocol and Safety Review Committee recommendations.
Read more
In Phase 1b, participants will receive PD-32766T at the recommended dose and schedule identified from Phase 1a to further evaluate safety, tolerability, and preliminary efficacy.
A total of up to 60 participants will be enrolled in the study.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- PD-32766D (a Copper-64 [64Cu] labeled peptide), PD-32766T (an Actinium-225 [225Ac] labeled peptide)
- Keywords
- ccRCC, Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), CA9, Actinium, Copper, Theranostics
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-32766D (a Copper-64 [64Cu] labeled peptide)Drug
After PD-32766D IV injection, undergo a PET/CT scan.
PD-32766T (an Actinium-225 [225Ac] labeled peptide)Drug
The PD-32766T of the specified dose per cycle is administered intravenously for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | PD-32766D is administered for imaging and then, subjects with positive tumor uptake will receive PD-32766T in recommended dose levels and schedule according Safety Review Committee. Receives: Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide); Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide) |
| Phase 1b Dose Expansion | Experimental | Subjects will receive PD-32766T in recommended dose levels and schedule. Receives: Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide); Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs).
Number of participants with DLT and DLT rate
Measured: Through completion of DLT evaluation (6weeks)
Incidence, intensity, seriousness, and causality of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse event of special interest (AESI) and serious adverse events (SAEs).
Number and proportion of participants with AEs, TEAEs, AESI and SAEs.
Measured: Through study completion, an average of 6 months.
Incidence of TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation.
Number and proportion of participants with TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation as a measure of tolerability.
Measured: Through study completion. an average of 6 months
Maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of PD-32766T based on dose-limiting toxicities.
MTD and RDE are determined based on the occurrence of DLTs during the DLT evaluation period.
Measured: Through completion of DLT evaluation (6weeks).
Secondary outcomes (4)
Area under the plasma concentration-time curve (AUC) of PD-32766T
Pharmacokinetic (PK) parameters based on radioactivity in the blood following the first dose administration of PD-32766T
Measured: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Maximum observed concentration (Cmax) of PD-32766T
Pharmacokinetic (PK) parameters based on radioactivity in the blood following the first dose administration of PD-32766T
Measured: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Urine PK profile of PD-32766T after IV injection
Radioactivity in the urine following the first dose administration: amount, cumulative amount, and fraction of the dosed radioactivity excreted in urine (Fe).
Measured: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Objective response rate (ORR), Disease control rate (DCR) and Duration of response (DoR) according to RECIST v1.1
Measured: Through study completion, an average 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start7 Jul 2026
- Primary completionMay 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PeptiDream Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688187
- Sponsor's protocol ID
- PD32766-101
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Phase 1a/1b, Dose Escalation/Dose Expansion Clinical Trial of Theranostic Pair PD-32766D, a 64Cu-Labeled Peptide and PD-32766T, an 225Ac-Labeled Peptide Targeting Carbonic Anhydrase IX in Adult Participants With Relapsed or Refractory Clear Cell Renal Cell Carcinoma Who Have Progressed From or Could Not be Administered Due to Medical Unsuitability or Limited Access to All Standard of Care Therapies
- ClinicalTrials.gov ID
- NCT07688187
- Acronym / sponsor ID
- PD32766-101
- Conditions
- Clear Cell Renal Cell Carcinoma
- Keywords
- ccRCC, Renal Cell Carcinoma (Kidney Cancer), Renal Cell Carcinoma (RCC), CA9, Actinium, Copper, Theranostics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PeptiDream Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter, Phase 1a/1b study evaluating the theranostic pair 64Cu-PD-32766 Injection (PD-32766D) and 225Ac-PD-32766 Injection (PD-32766T) in adult patients with relapsed or refractory Carbonic Anhydrase IX (CA9)-expressing clear cell renal cell carcinoma (ccRCC). The primary objective is to evaluate the safety and tolerability of PD-32766T, and to characterize its pharmacokinetics and preliminary antitumor activity.
Participants will first undergo imaging with PD-32766D to assess CA9 expression. Subjects with positive tumor uptake will be eligible to receive PD-32766T. In Phase 1a, PD-32766T will be administered in an escalating dose levels and schedule determined according to protocol and Safety Review Committee recommendations.
In Phase 1b, participants will receive PD-32766T at the recommended dose and schedule identified from Phase 1a to further evaluate safety, tolerability, and preliminary efficacy.
A total of up to 60 participants will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Escalation | Experimental | Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide), Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide)PD-32766D is administered for imaging and then, subjects with positive tumor uptake will receive PD-32766T in recommended dose levels and schedule according Safety Review Committee. |
| Phase 1b Dose Expansion | Experimental | Drug: PD-32766D (a Copper-64 [64Cu] labeled peptide), Drug: PD-32766T (an Actinium-225 [225Ac] labeled peptide)Subjects will receive PD-32766T in recommended dose levels and schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants aged ≥18 years.
- Participants with confirmed diagnosis of ccRCC will be included based on the following characteristics:
- Presence of positive tumor uptake
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- The participant's with adequate organ function
Key exclusion criteria (17 listed)
- Concurrent serious (as determined by the Investigator), uncontrolled medical conditions, or life-threatening or other significant comorbid conditions.
- Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic, investigational or hormonal therapy for treatment of solid tumors within 28 days.
- Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy.
- Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months.
- Any previous CA9 targeting treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-32766D (a Copper-64 [64Cu] labeled peptide)After PD-32766D IV injection, undergo a PET/CT scan. | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
| PD-32766T (an Actinium-225 [225Ac] labeled peptide)The PD-32766T of the specified dose per cycle is administered intravenously for up to 6 cycles. | Drug | Phase 1a Dose Escalation, Phase 1b Dose Expansion |
Primary outcome
Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs).
Time frame: Through completion of DLT evaluation (6weeks)
Number of participants with DLT and DLT rate
Incidence, intensity, seriousness, and causality of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse event of special interest (AESI) and serious adverse events (SAEs).
Time frame: Through study completion, an average of 6 months.
Number and proportion of participants with AEs, TEAEs, AESI and SAEs.
Incidence of TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation.
Time frame: Through study completion. an average of 6 months
Number and proportion of participants with TEAEs leading to dose delay, dose interruption, dose reduction, and/or discontinuation as a measure of tolerability.
Maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of PD-32766T based on dose-limiting toxicities.
Time frame: Through completion of DLT evaluation (6weeks).
MTD and RDE are determined based on the occurrence of DLTs during the DLT evaluation period.
4 secondary outcomes
Area under the plasma concentration-time curve (AUC) of PD-32766T
Time frame: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Maximum observed concentration (Cmax) of PD-32766T
Time frame: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Urine PK profile of PD-32766T after IV injection
Time frame: Through completion of 6 cycles (each cycle is 4 or 6 weeks)
Objective response rate (ORR), Disease control rate (DCR) and Duration of response (DoR) according to RECIST v1.1
Time frame: Through study completion, an average 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PD-32766D (a Copper-64 [64Cu] labeled peptide) and PD-32766T (an Actinium-225 [225Ac] labeled peptide) in people with Clear Cell Renal Cell Carcinoma, run by PeptiDream Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Lead (044-270-1300, PD_CA9_clinical@peptidream.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants who experience at least 1 dose-limiting toxicities (DLTs). (time frame: Through completion of DLT evaluation (6weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.