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Oncology remains one of the most active areas in global clinical development. As we move into the first half of 2026, however, industry attention is shifting. The key question is no longer simply whether ADCs, bispecific antibodies, or cell therapies are generating more momentum, but which programs can deliver interpretable, verifiable, and registration-enabling clinical value in clearly defined patient populations.
According to IQVIA’s Global Oncology Trends 2025, 2,162 oncology trials were initiated globally in 2024, representing an increase of approximately 12% compared with 2019. Novel oncology modalities, including cell and gene therapies, ADCs, and multispecific antibodies, now account for about 35% of oncology trials [1].
This suggests that oncology innovation continues to concentrate around new mechanisms and new platforms. Yet based on publicly available data from the first half of 2026, competition is no longer only about “who can enter clinical development faster,” but rather about “who can demonstrate true clinical benefit faster while addressing safety, dose selection, patient enrichment, and global registration pathways.”
ADCs remain one of the core hotspots in oncology clinical development in H1 2026. However, competition in the ADC space is no longer defined only by targets such as HER2, TROP2, CLDN6, and B7-H3. Instead, the real differentiators are whether target expression, payload/linker design, bystander effect, toxicity profile, dose selection, and combination strategy can create a meaningful overall advantage.
Several early-stage ADC studies disclosed at AACR 2026 are worth noting:
· HER2: A Phase I study of trastuzumab deruxtecan in combination with olaparib enrolled patients with HER2-expressing advanced or recurrent solid tumors; the reported cohort included patients with ovarian cancer and uterine cancer. The study showed a 6-month PFS rate of 88.2%, a confirmed ORR of 46%, and established a recommended Phase II dose [2].
· EGFR: SYS6010 showed an ORR of 31.5% and a DCR of 87% in patients with advanced nasopharyngeal carcinoma. From a safety perspective, all patients experienced at least one grade 1 or higher treatment-emergent adverse event (TEAE), and 64.1% experienced grade 3 or higher TEAEs, primarily hematologic toxicities [2].
· CLDN6: QLS5132 showed an ORR of 50% and a DCR of 94.4% in platinum-resistant ovarian cancer. However, this remains an early-stage, single-arm study with a limited sample size. In addition, responses were also observed in patients with low or undetectable CLDN6 expression, suggesting that biomarker cutoffs and the true benefiting population require further clarification [2].
· B7-H3: Risvutatug rezetecan in combination with adebrelimab showed a confirmed ORR of 47.1%, a DCR of 94.1%, and a median PFS of 14 months in previously treated patients with advanced non-squamous NSCLC without actionable targetable mutations. However, these data came from a subgroup in a Phase I study and still require validation in larger and randomized controlled studies [2].
Therefore, the next-stage differentiator for ADCs is not simply whether the response rate looks impressive. Three questions are becoming more important: first, whether toxicity is manageable, particularly platform-related risks such as hematologic toxicity, ILD/pneumonitis, ocular toxicity, and mucosal toxicity; second, whether the biomarker strategy is sufficiently clear to explain “who truly benefits”; and third, whether dose and regimen selection have been adequately optimized rather than merely pursuing higher exposure.
Bispecific antibodies have established a strong clinical presence in hematologic malignancies, but bispecifics in solid tumors remain in a more complex validation stage.
A 2026 review of bispecific antibody trials in colorectal cancer included 192 related studies conducted between 2011 and 2025. The review showed that PD-1/CTLA-4 and PD-1/VEGF were among the most common target combinations, while newer combinations such as EGFR/cMET were also increasing [3]. This indicates that bispecific antibodies in solid tumors are moving from proof of concept toward clinical validation in more stratified settings.
Among these, PD-1/VEGF bispecific antibodies have been one of the most closely watched directions in H1 2026. HARMONi-6 data presented at ASCO 2026 showed that in a Phase III study conducted in China in first-line advanced squamous NSCLC, ivonescimab plus chemotherapy significantly improved OS compared with tislelizumab plus chemotherapy, with an HR of 0.66 and 24-month OS rates of 64.7% and 48.6%, respectively [4].
However, such results should still be interpreted with caution. HARMONi-6 was a single-region study conducted in China, and global generalizability will require further validation in multiregional studies. At the same time, safety should not be overshadowed by efficacy data. In this study, treatment-related serious adverse events occurred in 41.4% of patients in the ivonescimab plus chemotherapy arm and 34.3% in the control arm; grade 3 or higher bleeding events occurred in 2.6% and 0.8% of patients, respectively [4]. For bispecific antibodies involving the VEGF pathway, potential risks such as bleeding, proteinuria, and hypertension still need to be continuously assessed across tumor types and patient populations.
Therefore, the key question for bispecific antibodies in solid tumors is not whether the mechanism is novel, but whether the therapeutic window is sufficient, whether the combination truly adds incremental benefit, whether biomarkers can guide patient selection, and whether global registrational studies can reproduce early-stage or single-region results.
CAR T-cell therapy remains primarily driven by hematologic malignancies. An analysis based on ClinicalTrials.gov showed that among 1,580 CAR-T clinical trials, hematologic malignancies accounted for 71.6%, while solid tumors accounted for 24.6% [5].
Solid-tumor CAR-T is growing rapidly. In solid-tumor CAR-T, targets such as MSLN/MESO, GPC3, GD2, CLDN18.2, and HER2 have shown relatively fast growth [5]. However, solid tumors are not a simple extension of the hematologic malignancy experience. They present multiple challenges, including antigen heterogeneity, an immunosuppressive tumor microenvironment, insufficient T-cell infiltration, on-target/off-tumor toxicity risks, manufacturing cost, and long-term follow-up requirements.
As a result, competition in cell therapy for solid tumors is not about a single target or a single construct. It is a system-level competition across target selection, cell engineering, manufacturing process, site capability, safety monitoring, and long-term follow-up. In the near term, solid-tumor CAR-T appears more like a continuing area of technical and clinical exploration than a mature field that has already entered large-scale confirmatory development.
Taken together, the keyword for oncology clinical trials in H1 2026 is not “more crowded,” but “more precise.”
ADCs are shifting from target competition to platform competition, but hematologic toxicity, ILD/pneumonitis, biomarker cutoffs, and dose optimization remain key challenges.
Bispecific antibodies are moving from mechanistic innovation toward solid-tumor validation, but the therapeutic window, component contribution in combination regimens, extrapolation of regional data, and global registration pathways still require cautious assessment.
Cell therapy is moving from success in hematologic malignancies toward the challenge of solid tumors, but antigen heterogeneity, tumor infiltration, manufacturing feasibility and accessibility, and long-term follow-up remain core bottlenecks.
This also explains why the regulatory perspective is becoming increasingly important. FDA guidance on optimizing the dosage of oncology drugs emphasizes that sponsors should identify an optimized dosage before submitting an application for a new indication, rather than simply relying on the traditional maximum tolerated dose (MTD) paradigm [6]. This is particularly relevant for ADCs and bispecific antibodies: ADCs must strike a balance among payload exposure, cumulative toxicity, and efficacy, while bispecific antibodies require more refined clinical pharmacology evidence around starting dose, step-up dosing strategy, dosing interval, and management of immune-related toxicities.
At the same time, global evidence-generation capability is becoming more important. Research on the WHO/ICTRP global landscape of cancer clinical trials shows that cancer trials remain highly concentrated in high-income countries, and multinational collaboration accounts for only a limited share of recruiting trials [7]. For Chinese innovation programs, early clinical speed and patient access are strengths. However, if the goal is global registration, sponsors must plan earlier for multiregional study design, participant representativeness, endpoint acceptability, assay consistency, and regulatory communication strategy.
As oncology R&D enters a new stage of precision evidence generation, truly valuable clinical research is not only about faster study start-up and faster enrollment. It also requires scientific study design, high-quality data, and a global perspective to help innovative therapies move more steadily toward patients.
In this sense, the oncology clinical trial hotspots of H1 2026 are not limited to ADCs, bispecific antibodies, or cell therapies themselves. The broader industry is shifting from “technology-platform enthusiasm” to competition in “evidence-generation capability.” Those who can define benefiting populations earlier, optimize dose and safety management more rationally, and plan global clinical development pathways more systematically will be more likely to translate early clinical signals into sustainable patient benefit.
[1] IQVIA Institute. Global Oncology Trends 2025.
[2] AACR Annual Meeting News. Second Clinical Trials Plenary highlighted results of next-generation antibody-drug conjugates. 2026.
[3] Shao W, et al. Clinical trials of bispecific antibody therapy for colorectal cancer: advanced and next steps. Frontiers in Oncology. 2026.
[4] ASCO 2026; Summit Therapeutics. Ivonescimab with chemotherapy demonstrated a statistically significant overall survival benefit compared to tislelizumab plus chemotherapy in 1L treatment of patients with squamous NSCLC in the HARMONi-6 study conducted by Akeso in China. 2026.
[5] Cao LY, et al. CAR-T cell therapy clinical trials: global progress, challenges, and future directions from ClinicalTrials.gov insights. Frontiers in Immunology. 2025.
[6] U.S. FDA. Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases. Guidance for Industry. 2024.
[7] Casolino R, et al. The WHO global landscape of cancer clinical trials. Nature Medicine. 2025; WHO Global Observatory on Health Research and Development. WHO landscape of clinical trials on cancer. 2025.