Small Cell Lung Cancer ( SCLC )Phase 1/2MYCrocyticNCT07864207
Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP- 121 in Patients With Platinum-resistant Small Cell Lung Cancer (MYCrocytic)
A Phase 1/2 study testing IDP-121 in people with Small Cell Lung Cancer ( SCLC ), run by IDP Discovery Pharma S.L. at 10 sites in Spain.
Trial summary
Phase 1/2 clinical trial is to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of IDP-121 combined with chemotherapy in patients with advanced unresectable/metastatic SCLC that have progressed after 1st line platinum- based chemotherapy, considering the role of MYC amplification in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer ( SCLC )
- What is being tested?
- IDP-121
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesSpain
- Study dates
- 28 Jul 2026to 30 Jul 2028
- Phase
- Phase 1/2
- 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
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥2 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study- related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patients diagnosed with advanced/extensive stage SCLC that have platinum-sensitive relapse after 1st line treatment defined as a Progression Free Interval (PFI) of ≥ 3 months (platinum-based chemotherapy plus IDP-121 arm) and patients with a PFI < 3 months (topotecan plus IDP-121 arm).
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- Adequate haematological or biochemical parameters as specified below
- b. Haemoglobin > 8.0 g/dl (without transfusion support within 7 days) Platelets count > 100 x109/L (without transfusion support within 7 days). c. Absolute neutrophil count (ANC) > 1.5 x109/L (without G-CSF support within 7 days) d. Aspartate transaminase (AST): <2.5 x the upper limit range. e. Alanine transaminase (ALT): < 2.5 x the upper limit range. f. Total bilirubin: < 2 x the upper limit range. g. Calculated or measured creatinine clearance: ≥ 60 mL/min (calculated from the Cockcroft-Gault formula).
- Left ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.
Who cannot join
- Persistent clinically significant or grade 3 or 4 non-haematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.
- Active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases (e.g., whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) may participate only if they satisfy the following:
- 4. 5. 6. 7. 8. 9. • Completed treatment at least 14 days prior to the first dose of study intervention.
- Are clinically stable, without requirement of steroid treatment > 10 mg or prednisone or equivalent for at least 7 days prior to first dose of study intervention. Pregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site) History of clinically significant hypotension. History of clinically significant allergic or hyper-sensitivity reactions. History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to): - Thromboembolism - Peripheral arterial disease
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- Vasculitis
- Other relevant diseases or adverse clinical conditions:
- Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).
- History of significant neurological or psychiatric disorders Clinically significant or active infection.
- 10. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis) 11. The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels <50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive). 12. Concomitant anti-tumour therapy within 14 days prior to Day 1 of Cycle 1. 13. Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment 14. Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- 15. If a COVID-19 vaccine is administered, it should be done >72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase").
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Not yet recruiting
Hospital del Mar
Barcelona
- Not yet recruiting
ICO Badalona Germans trias i Pujol
Barcelona
- Not yet recruiting
Hospital Universitario Gran Canaria
Las Palmas de Gran Canaria
- Recruiting
Clinica Universidad de Navarra (CUN)
Madrid
- Recruiting
Hospital Regional Universitario de Málaga
Málaga
- Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia
- Recruiting
Clinica Universidad de Navarra (CUN)
Pamplona
- Recruiting
Hospital Universitario de Navarra
Pamplona
- Not yet recruiting
Hospital Universitario Nstra Señora de Candelaria
Santa Cruz de Tenerife
- Recruiting
Hospital Clínico de Valencia
Valencia
About this study
Phase 1/2 clinical trial is to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of IDP-121 combined with chemotherapy in patients with advanced unresectable/metastatic SCLC that have progressed after 1st line platinum- based chemotherapy, considering the role of MYC amplification in the development of platinum resistance.
- Conditions
- Small Cell Lung Cancer ( SCLC )
- Being tested
- IDP-121
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-121Drug
IDP-121
| Study group | Role | What they receive |
|---|---|---|
| IDP-121 with Topotecan | Experimental | IDP-121 in combination with topotecan in patients with relapsed SCLC with PFI < 3 months Receives: Drug: IDP-121 |
| IDP-121 with platinum-based chemotherapy | Experimental | IDP 121 in combination with platinum-based chemotherapy in patients with relapsed SCLC and PFI ≥ 3 months Receives: Drug: IDP-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and RP2D
To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 combined with chemotherapy (topotecan day 1 to 5 every 3 weeks; carboplatin day 1 plus etoposide days 1, 2 and 3 every 3 weeks) in patients with SCLC.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start28 Jul 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer ( SCLC )Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an open-label, multicenter, phase 1/2 study with two arms in which IDP-121 is administered four times in a period of 21 days in combination with topotecan in patients with relapsed SCLC with PFI \< 3 months (Arm A) and in combination with platinum-based chemotherapy in patients with relapsed SCLC and PFI ≥ 3 months (Arm B).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDP Discovery Pharma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864207
- Sponsor's protocol ID
- IDP-121-2
- Acronym
- MYCrocytic
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP- 121 in Patients With Platinum-resistant Small Cell Lung Cancer (MYCrocytic)
- ClinicalTrials.gov ID
- NCT07864207
- Acronym / sponsor ID
- MYCrocytic / IDP-121-2
- Conditions
- Small Cell Lung Cancer ( SCLC )
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IDP Discovery Pharma S.L.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 7 Oct 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.
Phase 1/2 clinical trial is to evaluate the safety, pharmacokinetics and pharmacodynamics of escalating doses of IDP-121 combined with chemotherapy in patients with advanced unresectable/metastatic SCLC that have progressed after 1st line platinum- based chemotherapy, considering the role of MYC amplification in the development of platinum resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an open-label, multicenter, phase 1/2 study with two arms in which IDP-121 is administered four times in a period of 21 days in combination with topotecan in patients with relapsed SCLC with PFI < 3 months (Arm A) and in combination with platinum-based chemotherapy in patients with relapsed SCLC and PFI ≥ 3 months (Arm B).
| Arm | Type | Receives |
|---|---|---|
| IDP-121 with Topotecan | Experimental | Drug: IDP-121IDP-121 in combination with topotecan in patients with relapsed SCLC with PFI < 3 months |
| IDP-121 with platinum-based chemotherapy | Experimental | Drug: IDP-121IDP 121 in combination with platinum-based chemotherapy in patients with relapsed SCLC and PFI ≥ 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥2 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study- related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Key exclusion criteria (13 listed)
- Persistent clinically significant or grade 3 or 4 non-haematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.
- Active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases (e.g., whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) may participate only if they satisfy the following:
- 4. 5. 6. 7. 8. 9. • Completed treatment at least 14 days prior to the first dose of study intervention.
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site) History of clinically significant hypotension. History of clinically significant allergic or hyper-sensitivity reactions. History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to): - Thromboembolism - Peripheral arterial disease
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 |
|---|---|---|
| IDP-121IDP-121 | Drug | IDP-121 with Topotecan, IDP-121 with platinum-based chemotherapy |
Primary outcome
MTD and RP2D
Time frame: 1 year
To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 combined with chemotherapy (topotecan day 1 to 5 every 3 weeks; carboplatin day 1 plus etoposide days 1, 2 and 3 every 3 weeks) in patients with SCLC.
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 7 Oct 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDP-121 in people with Small Cell Lung Cancer ( SCLC ), run by IDP Discovery Pharma S.L. at 10 sites in Spain.
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 9 inclusion and 13 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 David Molina, Doctor (+34 669 616 086, d.molina@idp-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD and RP2D (time frame: 1 year). 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 7 Oct 2026.