Primary Outcome Measures
- Incidence of Dose Limiting Toxicities (DLTs)
- 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])
- Frequency of dose interruptions/reductions
- Duration of dose interruptions/reductions
Secondary Outcome Measures
- Assessment of the maximum observed serum concentration (Cmax)
- Assessment of the the minimum observed serum concentration (Cmin)
- Time from dosing at which maximum observed serum concentration is apparent (Tmax)
- Assessment of the terminal phase (apparent elimination) rate constant (λz)
- Assessment of the elimination half-life (t½)
- Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity])
- Assessment of the area under serum concentration-time curve over dosing interval (AUCtau)
- Assessment of clearance (CL) of NM32-2668 in serum
- Assessment of the volume of distribution (Vd) of NM32-2668 in serum
- Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum
- Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum
- Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum
- Frequency of specific anti-drug antibodies (ADAs) to NM32-2668
- Concentration of specific ADAs to NM32-2668
- Incidence of specific ADAs by category to NM32-2668
- Best Overall Response (BOR) according to RECIST 1.1
- Overall Response Rate (ORR) according to RECIST 1.1
- Disease Control Rate (DCR) according to RECIST 1.1
- Progression-free Survival (PFS) according to RECIST 1.1
- Time to Response (TTR) according to RECIST 1.1
- Duration of Response (DOR) according to RECIST 1.1
- Overall Survival (OS)
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
