Cervical CancerPhase 1NCT05283330
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors
A Phase 1 study testing ²¹²Pb-DOTAM-GRPR1 in people with Cervical Cancer and Breast Cancer, run by Orano Med Theranostics, SAS at 8 sites in United States.
Trial summary
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Breast Cancer, Colon Cancer
- What is being tested?
- ²¹²Pb-DOTAM-GRPR1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Dec 2022to May 2032
- 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
- Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):
- Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)
- HR+/HER2- breast cancer (estrogen receptor/ER expression >10% of tumor cell nuclei stain, regardless of progesterone receptor/PgR expression); HER2-negative including HER2-low (as per relevant ASCO/CAP guidelines)
- Colorectal cancer
- Cervical cancer
- Non-small-cell lung cancer (NSCLC)
- Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.
- Capable of giving signed informed consent
- All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB
- For participants with mCRPC: Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L)
- Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT/CT (uptake greater than that of the background) as assessed by the Investigator.
- For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions > uptake in background is acceptable for eligibility.
- Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.
- Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:
- White blood cell (WBC) ≥3000/ mm3 (≥ 3 x 109/L)
- Absolute neutrophil count (ANC) ≥1500/mm3 (≥1.5 x 109/L)
- Platelets ≥100,000/mm3 (≥ 100 x 109/L)
- Hemoglobin (Hb) ≥9.0 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases
- Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN
- Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL/min calculated as follows: CLCR = eGFR in ml/min/1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73
- Serum amylase and/or lipase ≤1.5 x ULN
- For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last [212Pb]Pb-DOTAM-GRPR1 administration or for 10 days following [203Pb]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol. Participants with Recurrent Glioblastoma:
- Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.
- Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT/CT scan in the tumor lesion(s).
- Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 7 recruiting
- Active, not recruiting
Northwestern University Robert H Lurie Medical Research
Chicago, Illinois, 60611
- Recruiting
Advanced Molecular Imaging and Therapy
Glen Burnie, Maryland, 21061
443-333-1894
Michael Morris, MD
- Not yet recruiting
United Theranostics - Chesapeake
Glen Burnie, Maryland, 21061
Babak Saboury, MD
- Not yet recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
David Bushness, MD
- Recruiting
UK Markey Cancer Center
Lexington, Kentucky, 40536
859-323-7628
Eddy Yang, MD
- Recruiting
Nebraska Cancer Specialists (Midwest Cancer Center - Legacy)
Omaha, Nebraska, 68130
Samuel Mehr, MD
- Recruiting
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130
402-697-2229
Luke Nordquist, MD
- Not yet recruiting
University of Pittsburg Medical Center (UPCM)
Pittsburgh, Pennsylvania, 15219
Neeta Pandit Taskar, MD
About this study
Official title: A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors
Read the detailed description
In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, participants with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a BOIN design for the MAD cohorts. Dose escalation may proceed until the recommended MAD dose is determined. Up to six (2 SAD and 4 MAD) cohorts are expected to be enrolled. Participants will be treated with up to four cycles administered every 4 or 6 weeks. Once the recommended MAD dose is determined, the expansion cohorts of the study will commence. A dosimetry sub study will also be conducted in participants part of the dose escalation.
- Conditions
- Cervical Cancer, Breast Cancer, Colon Cancer, NSCLC, mCRPC (Metastatic Castration-resistant Prostate Cancer), Glioblastoma
- Being tested
- ²¹²Pb-DOTAM-GRPR1
- Keywords
- Metastatic Cancer, Advanced Cancer, Recurrent Cancer, Prostate Cancer, Castration-Resistant, Metastatic Prostate Cancer, Breast Cancer, Hormone Receptor Positive, Non-Small Cell Lung Cancer, Colorectal Cancer, Cervical Cancer, Glioblastoma, Recurrent, Radioligand Therapy, Targeted Radiation Therapy, Gastrin-Releasing Peptide Receptor or Bombesin receptor subtype-2, Targeted Alpha Therapy, Lead-212 Radiopharmaceutical Therapy, Lead-203 Radiopharmaceutical Diagnostic, SPECT/CT
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms, Colonic Neoplasms, Glioblastoma, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Recurrence, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
²¹²Pb-DOTAM-GRPR1Drug
²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.
| Study group | Role | What they receive |
|---|---|---|
| ²¹²Pb-DOTAM-GRPR1 | Experimental | In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 5.5 mCi +/- 10%. Receives: Drug: ²¹²Pb-DOTAM-GRPR1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1
Incidence of DLTs.
Measured: 14 months
Secondary outcomes (12)
To assess the safety and tolerability of 212Pb-DOTAM-GRPR1.
Measured as Incidence and severity of TEAEs and TESAEs.
Measured: 24 months
To assess the safety and tolerability of 203Pb-DOTAM-GRPR1.
Measured as Incidence and severity of TEAEs and TESAEs.
Measured: 24 months
To assess PK of ²¹²Pb-DOTAM-GRPR1
212Pb-DOTAM-GRPR1 radioactivity concentration as a function of time in whole blood, plasma and urine
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
ORR by RECIST1.1, DOR, PFS by Investigator assessment and OS.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
For participants with mCRPC, by Investigator assessment of ORR which is defined as a proportion of participants having a 'best overall response' (BOR) assessment of Complete Response (CR) or Partial Response (PR) as per PCWG3 guidelines.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
For participants with mCRPC, by Investigator assessment of DOR which is defined as the time from the first documented objective response of PR or CR by PCWG3, whichever occurs earlier, to disease progression or death.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
For participants with mCRPC, by Investigator assessment of PFS which is defined as the time from the start of study intervention to the date of first observed disease progression (Investigator's radiological assessment), clinical disease progression (Investigator's assessment) or death due to any cause as per PCWG3 guidelines.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
For participants with mCRPC, as Overall Survival (OS) is defined as the time from the date of the start of study intervention to the date of death due to any cause.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212-PbDOTAM-GRPR1.
For participants with recurrent GBM, by Investigator assessment of ORR which is defined as a proportion of participants having a 'best overall response' (BOR) assessment of Complete Response (CR) or Partial Response (PR) as per RANO 2.0 criteria.
Measured: 24 Months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
For participants with recurrent GBM, by Investigator assessment of DOR defined as the time from the first documented objective response of PR or CR by RANO v 2.0, whichever occurs earlier, to disease progression or death
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
For participants with recurrent GBM, Investigator assessment of PFS defined as the time from the start of study intervention to the date of first observed disease progression (Investigator's radiological assessment), clinical disease progression (Investigator's assessment) or death due to any cause as per RANO 2.0 criteria.
Measured: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
For participants with recurrent GBM, Overall Survival (OS) is defined as the time from the date of the start of study intervention to the date of death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start22 Dec 2022
- Primary completionJan 2027 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orano Med Theranostics, SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283330
- Sponsor's protocol ID
- OM-GRPR1-02
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.
PubMed 38753757Kunos CA, Fabian D, Napier D, Stonecypher MS, Duncan RM, Hurt J. Human gastrin- releasing peptide receptor expression in women with uterine cervix cancer. Front Oncol. 2023 Jan 25;13:1126426. doi: 10.3389/fonc.2023.1126426. eCollection 2023.
PubMed 36761980
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors
- ClinicalTrials.gov ID
- NCT05283330
- Acronym / sponsor ID
- OM-GRPR1-02
- Conditions
- Cervical Cancer, Breast Cancer, Colon Cancer, NSCLC, mCRPC (Metastatic Castration-resistant Prostate Cancer), Glioblastoma
- Keywords
- Metastatic Cancer, Advanced Cancer, Recurrent Cancer, Prostate Cancer, Castration-Resistant, Metastatic Prostate Cancer, Breast Cancer, Hormone Receptor Positive, Non-Small Cell Lung Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Orano Med Theranostics, SASIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 16 Mar 2022 (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.
A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors
Detailed description
In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, participants with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a BOIN design for the MAD cohorts. Dose escalation may proceed until the recommended MAD dose is determined. Up to six (2 SAD and 4 MAD) cohorts are expected to be enrolled. Participants will be treated with up to four cycles administered every 4 or 6 weeks. Once the recommended MAD dose is determined, the expansion cohorts of the study will commence. A dosimetry sub study will also be conducted in participants part of the dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ²¹²Pb-DOTAM-GRPR1 | Experimental | Drug: ²¹²Pb-DOTAM-GRPR1In the dose escalation portion, a classic 3+3 design will be utilized for the SAD cohorts and a Boin design for the MAD cohorts. Doses will be increased by approximately 30% in subsequent cohorts. The maximum total dose that may be administered to a subject per cycle is 5.5 mCi +/- 10%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ²¹²Pb-DOTAM-GRPR1²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist. | Drug | ²¹²Pb-DOTAM-GRPR1 |
Primary outcome
To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1
Time frame: 14 months
Incidence of DLTs.
12 secondary outcomes
To assess the safety and tolerability of 212Pb-DOTAM-GRPR1.
Time frame: 24 months
To assess the safety and tolerability of 203Pb-DOTAM-GRPR1.
Time frame: 24 months
To assess PK of ²¹²Pb-DOTAM-GRPR1
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212-PbDOTAM-GRPR1.
Time frame: 24 Months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
Time frame: 24 months
To evaluate the preliminary antitumor activity of 212Pb-DOTAM-GRPR1.
Time frame: 24 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 11 Jun 2026.
- Derived from this study: PubMed 38753757Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.
- Derived from this study: PubMed 36761980Kunos CA, Fabian D, Napier D, Stonecypher MS, Duncan RM, Hurt J. Human gastrin- releasing peptide receptor expression in women with uterine cervix cancer. Front Oncol. 2023 Jan 25;13:1126426. doi: 10.3389/fonc.2023.1126426. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ²¹²Pb-DOTAM-GRPR1 in people with Cervical Cancer and Breast Cancer, run by Orano Med Theranostics, SAS at 8 sites 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?
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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Orano Med LLC (469-638-0744, clinicaltrials@oranomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Recommended Phase 2 Dose (RP2D) of ²¹²Pb-DOTAM-GRPR1 (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283330, which also lists 2 linked publications.
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 11 Jun 2026.