Ovarian CarcinomaPhase 1NCT06299163
NM32-2668 in Adult Patients With Selected Advanced Solid Tumors
A Phase 1 study testing NM32-2668 in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Numab Therapeutics AG at 11 sites in United States.
Trial summary
This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma
- What is being tested?
- NM32-2668
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 May 2024to 18 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients with histologically confirmed, advanced-stage protocol-specified solid tumors.
- Confirmed ROR1 tumor expression.
- Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.
Who cannot join
- Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy.
- Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668.
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668.
- Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Mary Crowley Cancer Research
Dallas, Texas, 75230
Duke University
Durham, North Carolina, 27710
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors
This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
- Conditions
- Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma, Endometrial Cancer, Adenocarcinoma of Lung, Triple Negative Breast Cancer
- Being tested
- NM32-2668
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Adenocarcinoma of Lung, Triple Negative Breast Neoplasms, Liposarcoma, Leiomyosarcoma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM32-2668Biological
Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA) Tri-Specific Antibody
| Study group | Role | What they receive |
|---|---|---|
| NM32-2668 | Experimental | Not described Receives: Biological: NM32-2668 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
Measured: Through 28 days post-infusion
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS])
Measured: Through 50 days post-final dose administration
Frequency of dose interruptions/reductions
Measured: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
Duration of dose interruptions/reductions
Measured: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
Secondary outcomes (22)
Assessment of the maximum observed serum concentration (Cmax)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the the minimum observed serum concentration (Cmin)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Time from dosing at which maximum observed serum concentration is apparent (Tmax)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the terminal phase (apparent elimination) rate constant (λz)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the elimination half-life (t½)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of clearance (CL) of NM32-2668 in serum
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the volume of distribution (Vd) of NM32-2668 in serum
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Frequency of specific anti-drug antibodies (ADAs) to NM32-2668
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Concentration of specific ADAs to NM32-2668
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Incidence of specific ADAs by category to NM32-2668
Measured: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Best Overall Response (BOR) according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Overall Response Rate (ORR) according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Disease Control Rate (DCR) according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Progression-free Survival (PFS) according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)
Time to Response (TTR) according to RECIST 1.1
Measured: From date of randomization until the date of first documented treatment response according to RECIST 1.1
Duration of Response (DOR) according to RECIST 1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)
Overall Survival (OS)
Measured: From date of randomization until the date of death from any cause, assessed through study completion (on average, 1 year after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 May 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Numab Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299163
- Sponsor's protocol ID
- NB-NM032-2668-101
- Status last verified
- Jul 2025
- First submitted
- 26 Feb 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06299163
- Acronym / sponsor ID
- NB-NM032-2668-101
- Conditions
- Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma, Endometrial Cancer, Adenocarcinoma of Lung, Triple Negative Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Numab Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 7 Mar 2024 (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 a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NM32-2668 | Experimental | Biological: NM32-2668 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically confirmed, advanced-stage protocol-specified solid tumors.
- Confirmed ROR1 tumor expression.
- Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.
Key exclusion criteria (4 listed)
- Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy.
- Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668.
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668.
- Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions.
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 |
|---|---|---|
| NM32-2668Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA) Tri-Specific Antibody | Biological | NM32-2668 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Through 28 days post-infusion
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS])
Time frame: Through 50 days post-final dose administration
Frequency of dose interruptions/reductions
Time frame: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
Duration of dose interruptions/reductions
Time frame: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first
22 secondary outcomes
Assessment of the maximum observed serum concentration (Cmax)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the the minimum observed serum concentration (Cmin)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Time from dosing at which maximum observed serum concentration is apparent (Tmax)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the terminal phase (apparent elimination) rate constant (λz)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the elimination half-life (t½)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of clearance (CL) of NM32-2668 in serum
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of the volume of distribution (Vd) of NM32-2668 in serum
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Frequency of specific anti-drug antibodies (ADAs) to NM32-2668
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Concentration of specific ADAs to NM32-2668
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Incidence of specific ADAs by category to NM32-2668
Time frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation
Best Overall Response (BOR) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Overall Response Rate (ORR) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Disease Control Rate (DCR) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment
Progression-free Survival (PFS) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)
Time to Response (TTR) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented treatment response according to RECIST 1.1
Duration of Response (DOR) according to RECIST 1.1
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment)
Overall Survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed through study completion (on average, 1 year after last treatment)
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 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 NM32-2668 in people with Ovarian Carcinoma and Fallopian Tube Carcinoma, run by Numab Therapeutics AG at 11 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?
The sponsor lists 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: Through 28 days post-infusion). 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 23 Jul 2025.