Oncology Solid Tumor Areas of Interest

Compounds with areas of interest for Externally Sponsored Research are listed below. We aren’t accepting proposals at this time for the non-listed compounds.

Submissions are aligned to quarterly portal cut‑offs, with applications reviewed by intake cycle.

Brand or Substance	Submissions being Considered	Areas of Interest	Out of Scope
INLEXZO™ (gemcitabine intravesical system)	Portal open	Studies in high-risk non-muscle invasive bladder cancer Studies exploring novel biomarkers or translational research Deintensification strategies Intermediate risk non-muscle invasive bladder cancer	Muscle invasive bladder cancer Intermediate-risk bladder cancer Non-bladder cancer related studies Duplicative Research Safety as primary endpoint

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Brand or Substance	Submissions being Considered	Areas of Interest	Out of Scope
RYBREVANT® (amivantamab-vmjw)	Portal open	Lung Treatment sequencing subsequent to 1L ami/laz AE management supportive care (including patient perspectives) Change Disease Biology studies that position ami’s MoA (EGFRi, METi, immune cell activity) to enhance disease control studies that augment AMI’s MOA (macrophage/immune cell activity) or synergistic MOAs (pre-clinical evidence recommended) Studies evaluating CNS activity and protection Ami + Laz dose adaptability to maximize benefit with Ami in certain patient population Novel indication(s) & evidence-based guidelines as proof of concept (eg, novel AMI combos, earlier stage NSCLC) Head and Neck Effectiveness, safety and mechanism of action in 1L recurrent/metastatic HNSCC KRAS New patient subgroups or tumor types (eg, nasopharyngeal, thyroid; role of HPV) not yet evaluated in any line of therapy Unresectable, locally-advanced HNC Window of opportunity Resectable, locally-advanced HNC Window of opportunity Rational novel combinations with low risk of overlapping toxicity Mechanisms of resistance Translational research evaluating role of MET Biomarkers, immune activity	Safety-only studies Study time horizon (FPI to TLR) exceeds 4 years Any study that may restrict use in approved indications Any lazertinib study not involving amivantamab Head and Neck Duplicative with CSS (existing or planned) or IIS/Collaborative (active or approved) Study competes with CSS enrollment Safety-only studies Multi-company collaborations are not recommended Study time horizon (FPI to TLR) exceeds 4 years Low recruitment or poor feasibility risk assessment

Brand or Substance

Submissions being Considered

Areas of Interest

Out of Scope

RYBREVANT® (amivantamab-vmjw)

Portal open

Lung

Treatment sequencing subsequent to 1L ami/laz
AE management supportive care (including patient perspectives)
Change Disease Biology
- studies that position ami’s MoA (EGFRi, METi, immune cell activity) to enhance disease control
- studies that augment AMI’s MOA (macrophage/immune cell activity) or synergistic MOAs (pre-clinical evidence recommended)
Studies evaluating CNS activity and protection
Ami + Laz dose adaptability to maximize benefit with Ami in certain patient population
Novel indication(s) & evidence-based guidelines as proof of concept (eg, novel AMI combos, earlier stage NSCLC)

Head and Neck

Effectiveness, safety and mechanism of action in 1L recurrent/metastatic HNSCC KRAS
New patient subgroups or tumor types (eg, nasopharyngeal, thyroid; role of HPV) not yet evaluated in any line of therapy
Unresectable, locally-advanced HNC
- Window of opportunity
Resectable, locally-advanced HNC
- Window of opportunity
Rational novel combinations with low risk of overlapping toxicity
Mechanisms of resistance
Translational research evaluating role of MET

Biomarkers, immune activity

Safety-only studies
Study time horizon (FPI to TLR) exceeds 4 years
Any study that may restrict use in approved indications
Any lazertinib study not involving amivantamab

Head and Neck

Duplicative with CSS (existing or planned) or IIS/Collaborative (active or approved)
- Study competes with CSS enrollment
- Safety-only studies
- Multi-company collaborations are not recommended
- Study time horizon (FPI to TLR) exceeds 4 years
- Low recruitment or poor feasibility risk assessment

Click here to make a submission