A Phase 1/2 interventional study of [212Pb]Pb-MP0712 and [203Pb]Pb-MP0712 in Large Cell Neuroendocrine Carcinoma, Large Cell Pulmonary Neuroendocrine Carcinoma of the Lung (LCNEC) and Extrapulmonary Neuroendocrine Carcinoma (EP-NEC), sponsored by Molecular Partners AG. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Molecular Partners AG · Phase 1/2, Interventional, and Treatment
Among 629 studies in Small Cell Lung Carcinoma with a site in United States — 112 open to participants now, 182 under way, 27 of them phase 3. Small Cell Lung Carcinoma · United States.
Among the 629 studies in Small Cell Lung Carcinoma with a site in United States, this one is the 149th largest by planned enrollment of the 550 interventional ones that give a count, is one of 37 that started in 2026, is one of 113 in phase 1/2, reaches primary completion later than 122 of the 181 other live ones, and was the 599th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
Browse Small Cell Lung Carcinoma studies →112 of the 629 studies in Small Cell Lung Carcinoma with a site in United States are open now. Recruiting first, the newest first:
Misty Shields · Sites in United States
Ohio State University Comprehensive Cancer Center · Sites in United States
National Cancer Institute (NCI) · Sites in United States
Jazz Pharmaceuticals · Sites in United States
Boehringer Ingelheim · Sites in United States, Australia, Belgium and 7 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 264 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 67 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
629 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 295 · Phase 2 302 · Phase 3 55 · Phase 4 3
First in 1991; this study’s year is marked. 37 started in 2026.
This study's planned enrollment of 138 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 55 across the 550 interventional studies, 111 across the 51 observational. Of the 417 that completed or were terminated, 173 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
294 of 629 have an industry lead sponsor. The 10 most frequent:
Molecular Partners AG is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Molecular Partners AG has 1 study filed under Small Cell Lung Carcinoma — fewer than ten, so there is no comparison to draw.
44 of the studies in Small Cell Lung Carcinoma with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01064466Phase 3Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB ChairPharmacogenomics ANDA SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT06646276Phase 3Bristol-Myers SquibbA Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). | 2027-08-17 |
| NCT07778316Phase 3AmgenPhase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) | 2027-09-24 |
| NCT04624204Phase 3Merck Sharp & Dohme LLCPlacebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) | 2027-10-28 |
| NCT07473128Phase 3Pharmacosmos A/SEffect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer | 2027-10-31 |
Among the 629 studies in Small Cell Lung Carcinoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [212Pb]Pb-MP0712, in patients aged ≥18 years with Small Cell Lung Cancer and other locally advanced or metastatic DLL3 positive tumors.
This is a phase I/IIa, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of [212Pb]Pb-MP0712 in patients with SCLC and other advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) [212Pb]Pb-MP0712 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of [212Pb]Pb-MP0712. The study will enable evaluation of the safety, dosimetry, PK, and imaging properties of [203Pb]Pb-MP0712.
Key Inclusion Criteria:
or cytologically confirmed: I. advanced extensive or limited SCLC or LC NECs of the lung
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive \[203Pb\]Pb-DOTAM-MAM279 for Imaging/Dosimetry followed by \[212Pb\]Pb-DOTAM-MAM279 for treatment
Drug: [212Pb]Pb-MP0712 · Other: [203Pb]Pb-MP0712
Radioligand Therapy
Also known as: [212Pb]Pb-DOTAM-MAM279
Radioligand Imaging Agent
Also known as: [203Pb]Pb-DOTAM-MAM279
To assess incidence and severity of safety events following administration of [212Pb]Pb-DOTAM-MAM279
Type, frequency and severity of adverse events (AEs), and serious adverse events (SAEs), Adverse events of special interest (AESI) and Dose Limiting Toxicities (DLT) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: until 5 years after last dose
To assess dose modifications of [212Pb]Pb-DOTAM-MAM279
Frequency and duration of dose changes
Time frame: until 5 years after last dose
To estimate the maximum tolerated dose (MTD) and/or to define the recommended phase 2 dose (RP2D) for SCLC/LCNEC of the lung and epNECs
Incidence of dose limiting toxicities
Time frame: Phase 1, from start of treatment to end of first cycle (day 1 - 28)
To evaluate the preliminary anti-tumor activity of [212Pb]Pb-DOTAM-MAM279 in the dose expansion part
Objective Response Rate (ORR) in the expansion phase ORR is defined as the percentage of patients with partial response (PR) or complete response (CR) as per RECIST v1.1
Time frame: Phase 2a only; 12 months
To assess maximum concentration (Cmax) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Blood and serum samples will be drawn to determine maximum concentration (Cmax) of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the area under the curve (AUC) from time 0 to the time of the last quantifiable concentration of [203Pb]Pb-DOTAM-MAM279
Blood and serum samples will be drawn to determine AUC of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess half-live(s) (t½) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Blood and serum samples will be drawn to determine half-live(s) (t½) of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the clearance (CL) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Blood and serum samples will be drawn to determine clearance (CL) of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To assess the volume of distribution (Vd) of [203Pb]Pb-DOTAM-MAM279 / [212Pb]Pb-DOTAM-MAM279
Blood and serum samples will be drawn to determine the volume of distribution (Vd) of \[203Pb\]Pb-DOTAM-MAM279 / \[212Pb\]Pb-DOTAM-MAM279
Time frame: up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration; up to 14 days following [212Pb]Pb-DOTAM-MAM279 administration]
To quantitatively predict radiation absorbed doses for therapeutic [212Pb]Pb-DOTAM-MAM279 from [203Pb]Pb-DOTAM-MAM279
Estimation of \[212Pb\]Pb-DOTAM-MAM279 absorbed dose for healthy organs and tumor lesions based on dosimetry analysis of \[203Pb\]Pb-DOTAM-MAM279
Time frame: Phase 1; up to 7 days following [203Pb]Pb-DOTAM-MAM279 administration
To assess incidence and severity of safety events following administration of [203Pb]Pb-DOTAM-MAM279
Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: up to 10 days following [203Pb]Pb-DOTAM-MAM279 administration
To evaluate PFS
Progression-Free Survival (PFS) determined as the time from C1D1 to the date of progression, defined as the first documented progression as per RECIST v1.1 or death for any cause
Time frame: Phase 2a only; 12 months
To evaluate DoR
Duration of response (DoR) in patients with a CR or PR from date of first date of response to the date of RECIST 1.1 progression or death
Time frame: Phase 2a only; 12 months
To evaluate DCR
Disease control rate (DCR) defined as the percentage of patients who have achieved CR, PR, or stable disease (SD)
Time frame: Phase 2a only; 12 months
To evaluate OS
Overall survival (OS) defined as the time from C1D1 to death from any cause
Time frame: Phase 2a only; approx. 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2028, 28 months after the start.
Of 70 industry-sponsored phase 1/2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 74. This study's planned 28 months is below that.
Counting every sponsor, half of 97 studies reached it within 56 months; a quarter within 44 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Lead PB-212
Molecular Partners AG